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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 29, 2011

 

 
June 29, 2011                                                                                        11-26
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT
1) Kozykids ultra thick baby wipes, Recall # F-1408-2011;
 
2) Giant Cottontails baby wipes unscented, and Giant Cottontails sensitive baby wipes, FPO 6-88267-12363-4. Recall # F-1409-2011;
 
3) Stop & Shop Cottontails baby wipes unscented. FPO 6-88267-12363-4. Recall # F-1410-2011;
 
4) Lullabies All Purpose Wipes, Alcohol Free. UPC 0 42498 17652 5. Recall # F-1411-2011;
 
5) For Baby, America's Choice baby wipes, scented and unscented, UPC 7-54807-48115-8. Recall # F-1412-2011;
 
6) Home 360 Baby, baby wipes, unscented, UPC 7-25439-93274-5. Recall # F-1413-2011;
 
7) HyVee Mother's Choice baby wipes, fresh scent and fragrance free, UPC 0 75450 02339 8, and UPC 0 75450 02340 8. Recall # F-1414-2011; HyVee Mother's Choice baby wipes, fresh scent and fragrance free, UPC 0 75450 02339 8, and UPC 0 75450 02340 8. Recall # F-1414-2011;
 
8) Comforts For Baby, scented baby wipes, and fragrance free baby wipes, UPC codes: 0 41260 35219 5, 0 41260 35066 5, 0 41260 35070 2, 0 41260 35069 6 and 0 41260 35065. Recall # F-1415-2011;
 
9) Meijer Baby, softly scented, fragrance free, and shea butter wipes; UPC: 7 60236 94775 2, 7 60236 63739 4, 7 60236 63737 0, and 7 60236 94778 3. Recall # F-1416-2011;
 
10) Roundys Baby Wipes, Hypoallergenic, Alcohol Free, UPC: 0-11150-73225-3. Recall # F-1417-2011;
 
11) Compliments unscented baby wipes, UPC: 0-55742-37046-1, and 0 55742 35267 2. Recall # F-1418-2011;
 
12) Stater Bros. since 1936, Baby Wipes unscented and Baby Wipes scented, UPC 0-74175-05150-1, 0-74175-05168-6, and 0-74175-05167-9. Recall # F-1419-2011;
 
13) Baby Basics, fragrance free, baby wipes, UPC: 0 41163 46996 0. Recall # F-1420-2011;
 
14) Top Care Baby, Baby Soft Baby Wipes, Fragrance Free. UPC 0-36800-32682-8. Recall # F-1421-2011;
 
15) Best Choice Baby Wipes, unscented. Recall # F-1422-2011;
 
16) W Premium Thick Baby Wipes, Shea Butter with Aloe. Recall # F-1423-2011;
 
17) Moist Wipes packaged under the brand name Member's Mark; and Naturally Gentle Wipes packaged under the brand name Equate, fragrance free and shea butter, UPC: 0-78742-10367-90, 78742 02653 4, and 0 78742 14466 5. Recall # F-1424-2011
 
18) Kuddles, exclusively at Winn Dixie, Baby Wipes, fresh scent and fragrance free. UPC: 0-21140-00705; and 0-21140-00706. Recall # F-1425-2011
CODE
1) Lots 11021, 11022, 11050, 11062, and 11088. Lot codes are followed by a four digit code that is the time of manufacture based on a 24-hour clock;
 
2) Lots 11020, 11028, 11062, 11073, and 11087;
 
3) Lots 11032, 11048, 11049, 11062, 11074, and 11090;
 
4) Lots 11021, 11055, 11056, 11062, 11088, and 11089;
 
5) Lots: 11019, 11039, 11049, 11073, and 11090;
 
6) Lots: 11031, 11032, 11050, 11061, 11073, and 11088;
 
7) Lots 11041, 11055, and 11090;
 
8) Lots: 11020, 11022, 11028, 11031, 11039, 11040, 11041, 11049, 11050, 11054, 11055, 11056, 11074, 11087, 11088, and 11090;
 
9) Lots: 11021, 11022, 11023, 11033, 11040, 11041, 11042, 11054, 11055, 11073, and 11090;
 
10) Lots: 11021, 11032, and 11073;
 
11) Lots: 11045, 11054, 11060, and 11070;
 
12) Lots: 11034, 11039, 11061, 11062, 11073, and 11088;
 
13) Lots 11020, 11050, and 11091;
 
14) Lots 11021, 11061, and 11091;
 
15) Lots: 11039, and 11091;
 
16) Lots: 11042, 11049, 11073, and 11091;
 
17) Lots: 11019, 11020, 11023, 11024, 11025, 11026, 11027, 11028, 11034, 11035, 11036, 11037, 11038, 11039, 11043, 11044, 11045, 11046, 11047, 11048, 11050, 11051, 11052, 11053, 11054, 11057, 11058, 11059, 11060, 11061, 11063, 11064, 11065, 11066, 11067, 11068, 11069, 11070, 11071, 11075, 11076, 11077, and 11078;
 
18) Lots: 11020, 11022, 11054, 11055, 11061, 11088, and 11090
RECALLING FIRM/MANUFACTURER
Rockline Industries, Springdale, AR, by letter on April 12, 2011. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
938,822 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) White Sandwich Bread packaged under brand names Tender Crust Texas Toast 24 oz, UPC 41330-01006; ShurFine Thin Sliced, 24 oz., UPC 15400-21389; Tender Crust Thin Sliced, 24 oz., UPC 41330-01008; Allsup's Always Delicious Sandwich, 24 oz., UPC 00001-02001; Lowe's White, 24 oz., UPC 41330-09999; Thriftway Thin Sliced, 24 oz., UPC 41330-09979; and FCM White Sandwich UPC 70821-23461, 24-oz. allpurchased prior to May 2, 2011. Recall # F-1472-2011;
 
2) White Split Top Bread packaged under brand names Shurfine Large, 24 oz. UPC 15400-21377; Tender Crust Large, 24 oz, UPC 41330-01007; Lowe's Large Round Top, 24 oz, UPC 41330-01254; Thriftway Large, 24 oz, UPC 41330-09980; and Tender Crust Split Butter Flavored White, 24 oz., USPC 41330-01005, all purchased prior to May 2, 2011. Recall # F-1473-2011;
 
3) Open Top Wheat Bread packaged under brand names: Tender Crust Cracked Wheat, UPC 41330-10216; Tender Crust Stone Ground Wheat, UPC 41330-010001; Lowe's Split Top Wheat UPC 41330-01307; and Tender Crust Split Butter Flavored Wheat UPC 41330-01001; all 24 oz., purchased prior to May 2, 2011. Recall # F-1474-2011;
 
4) Wheat Sandwich Bread packaged under brand names Tender Crust Wheat Bread UPC 41330-01020; Lowe's Wheat UPC 41330-01306; Allsup's Wheat Sandwich UPC 00001-16013; ShurFine Wheat Sandwich, UPC 15400-84014; and Thriftway Wheat Sandwich, UPC 41330-09981, and FCM Wheat Sandwich, UPC 70821-70140; all 24 oz., purchased prior to May 2, 2011. Recall # F-1475-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Tri-State Baking Co., Amarillo, TX, by press release on May 5, 2011 and by email on May 6, 2011. FDA initiated recall is ongoing.
REASON
Product labeling does not declare soy flour, soy lecithin, and milk.
VOLUME OF PRODUCT IN COMMERCE
893,628 units
DISTRIBUTION
TX, NM, AZ, OK, KS, CO, AR
___________________________________
PRODUCT
Coombe Castle Royal Blue Stilton Cheese Product of England, Serving Size - 1 oz; 8-9 lb wheel distributed in one case. Batch Code B038. Recall # F-1476-2011
CODE
No specific expiration dates
RECALLING FIRM/MANUFACTURER
Atalanta Corp., Elizabeth, NJ, by letter on June 3, 2011 and by press release on June 14, 2011. Firm initiated recall is ongoing.
REASON
Royal Blue Stilton Cheese may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
8 cases- 7 cases returned intact, one case unaccounted for
DISTRIBUTION
CA, WI, IL
___________________________________
PRODUCT
1) Doctor's CarbRite Diet chocolate brownie Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081124. Recall # F-1477-2011;
 
2) Doctor's CarbRite Diet Toasted Coconut Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081025. Recall # F-1478-2011;
 
3) Doctor's CarbRite Diet Frosted Cinnamon Bun Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081100. Recall # F-1479-2011;
 
4) Doctor's CarbRite Diet Chocolate Mint Cookie Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081131. Recall # F-1480-2011;
 
5) Doctor's CarbRite Diet S'mores Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081148. Recall # F-1481-2011;
 
6) Doctor's CarbRite Diet Raspberry Chocolate Truffle Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081155. Recall # F-1482-2011;
 
7) Doctor's CarbRite Diet Chocolate Covered Banana Nut with Soy Nuts Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081186. Recall # F-1483-2011;
 
8) Doctor's CarbRite Diet Blueberry Cheesecake Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar (57 g), UPC 039442081193. Recall # F-1484-2011;
 
9) Doctor's CarbRite Diet Cookie Dough Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar ( 57 g) ,UPC 039442081865. Recall # F-1485-2011;
 
10) Doctor's CarbRite Diet Lemon Meringue Sugar Free Bar; Net Wt. 2.00 oz (56.7g) Serving Size - 1 bar ( 57 g) ,UPC 039442081896. Recall # F-1486-2011;
 
11) Universal Hi Protein Chocolate Brownie, Net Wt 3 oz (85 g) Serving Size 1 bar (85 g) UPC 039442080523. Recall # F-1487-2011;
 
12) Universal Hi Protein S'mores, Net Wt 3 oz (85 g) Serving Size 1 bar (85 g) UPC 039442080523. Recall # F-1488-2011
CODE
This recall affects only products expiring on or before June 30, 2012 (EXP 063012).
RECALLING FIRM/MANUFACTURER
Universal Protein Supplements Corp., New Brunswick, NJ, by press release on April 21, 2011 and May 10, 2011 and by letters on April 22, 2011 and May 10, 2011. Firm initiated recall is ongoing.
REASON
Products may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
155, 017 units
DISTRIBUTION
Nationwide and International
___________________________________
PRODUCT
Sunflower kernels in 25 lb. size bags and labeled in part: ecco pacific***CERTIFIED ORGANIC***PREMIUM BAKERY GRADE SUNFLOWER KERNELS***Net Wt.:25lbs/11.34kgs. Product packed in China. Recall # F-1489-2011
CODE
Lot number: 1012
RECALLING FIRM/MANUFACTURER
Organic Partners Int, LLC, Portland, OR, by telephone on October 29, 2010 and by letter on November 1, 2010. FDA initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1004 bags, 25lbs each
DISTRIBUTION
CO, CA, NE
___________________________________
PRODUCT
Quenby Hall Blue Stilton, Handmade Leicestershire Blue Veined Cheese; Product of England, Serving Size: 1 oz.; UPC 0813555010000. Recall # F-1490-2011
CODE
Lots 019 through 034 and marked with an expiration date of 6/15/2011 through 6/29/2011
RECALLING FIRM/MANUFACTURER
Schratter Foods, Inc., Fairfield, NJ, by letter on May 17, 2011 and by press release on May 18, 2011. Firm initiated recall is ongoing.
REASON
Quenby Hall Blue Stilton Cheese may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
0 cases of 8.5 wheels; 238 cases of 12 pieces each @ 5.29 oz
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Bob Evans Oven Bake Hash Brown Bake 20 oz (1 lb 4 oz) 567 g. In a black plastic tray with sealed film over top. Item UPC 0 75900-00613 1. Recall # F-1426-2011;
 
2) Bob Evans Bake Macaroni and Cheese 20 oz (1 lb 4 oz) 567 g. In a black plastic tray with sealed film over top. Item UPC 0 75900-00614 8; Case UPC 1 75900-00614 5. Recall # F-1427-2011
CODE
1) and 2) Use By Date of May/01/11 & Use By Date of May/18/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bob Evans Farms, Columbus, OH, by telephone, press release and letters on April 8, 2011.
Manufacturer: Reser's Fine Foods, Inc., Pasco, WA. Firm initiated recall is ongoing.
REASON
Product may contain undeclared allergens including egg and wheat.
VOLUME OF PRODUCT IN COMMERCE
165 cs/6 trays of Use By May/01/11 & 130 cs/6 trays of Use By May/18/11
DISTRIBUTION
MN, MO
___________________________________
PRODUCT
Fresh Cucumbers. Case label reads: "***C-B-I Since 1925*** - PRODUCE OF U.S.A***". Recall # F-1429-2011
CODE
Lot 47916
RECALLING FIRM/MANUFACTURER
J & J Produce, Inc., Loxahatchee, FL, by email, letter and telephone beginning May 24, 2011. FDA initiated recall is ongoing.
REASON
Firm is recalling fresh cucumbers after FDA laboratory analysis detected Salmonella.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Sockeye Salmon is packaged in a 7.5 oz metal can, 24 cans per case. Product is sold under brand name Quinault Pride Seafood. The UPC is 1 10126 00033 1. Blueback (Sockeye) Salmon is packaged in a 7.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00033 4. The Sockeye Salmon product is labeled in part: "***Quinault Pride Seafood***SOCKEYE SALMON***Net. Wt. 7.5 oz.***Ingredients: Salmon, salt added". The Blueback (Sockeye) Salmon product is labeled in part: "***QUINAULT BLUEBACK (SOCKEYE) SALMON***Quinault Pride Seafood***Net. Wt. 7.5 oz***Ingredients: Salmon, salt added”. 033: Product code for Sockeye; 078: Julian Date; 0: Year 2010; F: Batch code. Recall # F-1430-2011;
 
2) Smoked Coho Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood or Quinault Pride. The UPC is 0 10126 00064 8. The product is labeled in part: "***SMOKED COHO SALMON***Quinault Pride Seafood***Net. Wt. 6.5 oz***Ingredients: Salmon, salt added". The product is labeled in part: "***SMOKED COHO SALMON***Quinault Pride ***Net Wt. 6 ½ oz***Ingredients: Salmon, salt added".
Recall # F-1431-2011;
 
3) Smoked Quinault Blueback (Sockeye) Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00024 2. The product is labeled in part: "***SMOKED QUINAULT BLUEBACK (SOCKEYE) SALMON***Quinault Pride Seafood***Net. Wt. 6.5 oz***Ingredients: Salmon, salt added". Recall # F-1432-2011;
 
4) Coho Salmon is packaged in a 7.5 oz metal can, 24 cans per case. Brand name is Quinault Pride. The UPC is 1 10126 00032 2. The product is labeled in part: "***COHO SALMON***Quinault Pride ***Net Wt. 7 1/2 oz***Ingredients: Salmon, salt added". Recall # F-1433-2011;
 
5) King (Chinook) Salmon is packaged in a 7.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00031 0. The product is labeled in part: "***KING (CHINOOK) SALMON***Quinault Pride Seafood ***Net. Wt. 7.5 oz***Ingredients: Salmon, salt added". Recall # F-1434-2011;
 
6) Smoked King Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride. The UPC is 0 10126 00081 3. Smoked King (Chinook) Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00081 5. The Smoked King Salmon product is labeled in part: "***SMOKED KING SALMON ***Quinault Pride***Net Wt. 6 1/2 oz***Ingredients: Salmon, salt added". The Smoked King (Chinook) Salmon product is labeled in part: "***SMOKED KING (CHINOOK) SALMON ***Quinault Pride Seafood ***Net. Wt. 6.5 oz***Ingredients: Salmon, salt added". Recall # F-1435-2011;
 
7) Boneless and Skinless Smoked Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride or Quinault Pride Seafood. The UPC is 0 10126 00027 3. The Quinault Pride brand product is labeled in part: "***BONELESS AND SKINLESS SMOKED SALMON ***Quinault Pride***Net Wt. 6 1/2 oz***Ingredients: Salmon, salt added; The Quinault Pride Seafood brand product is labeled in part: "***Boneless & Skinless SMOKED SALMON ***Quinault Pride Seafood***Net. Wt. 6.5 oz. ***Ingredients: Salmon, salt added.  Recall # F-1436-2011;
 
8) Smoked Salmon is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride or Quinault Pride Seafood. The UPC is 0 10126 00020 4. The Quinaul Pride brand product is labeled in part: "***SMOKED SALMON ***Quinault Pride***Net Wt. 6 1/2 oz***Ingredients: Salmon, salt added. The Quinaul Pride Seafood brand product is labeled in part: "***SMOKED SALMON ***Quinaul Pride Seafood ***Net. Wt. 6.5 oz***Ingredients: Salmon, salt added. Recall # F-1437-2011
 
9) Line Caught Albacore Tuna is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride. The UPC is 0 10126 00040 2. The product is labeled in part: "***LINE CAUGHT ALBACORE TUNA***Quinault Pride***Net Wt. 6 1/2 oz***Ingredients: Tuna, salt added”. Recall # F-1438-2011;
 
10) Smoked Albacore Tuna is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00063 1. The product is labeled in part: "***SMOKED ALBACORE TUNA***Quinault Pride Seafood***Net Wt. 6.5 oz***Ingredients: Tuna, salt added. Recall # F-1439-2011;
 
11) Smoked Steelhead is packaged in a 6.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00071 6. The product is labeled in part: "***SMOKED STEELHEAD***Quinault Pride Seafood***Net Wt. 6.5 oz***Ingredients: Salmon, salt added. Recall # F-1440-2011;
 
12) Minced Razor Clams is packaged in a 5.5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood or Quinault Pride. The UPC is 0 10126 00010 5. The Quinault Pride Seafood product is labeled in part: "***MINCED RAZOR CLAMS***Quinault Pride Seafood***Net Wt. 5.5 oz***Ingredients: Clam, salt added". The Quinault Pride product is labeled in part: "***MINCED RAZOR CLAMS***Quinault Pride ***Net Wt. 5 1/2 oz.; Ingredients: Clam, salt added. Recall # F-1441-2011;
 
13) Smoked Razor Clams is packaged in a 5 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood. The UPC is 0 10126 00011 2. The product is labeled in part: "***SMOKED RAZOR CLAMS***Quinault Pride Seafood***Net Wt. 5 oz***Ingredients: Clam, salt added. Recall # F-1442-2011;
 
14) Smoked Sturgeon is packaged in a 6 oz metal can, 24 cans per case. Brand name is Quinault Pride Seafood or Quinault Pride. The UPC is 0 10126 00026 6. The Quinault Pride Seafood brand product is labeled in part: "***SMOKED STURGEON***Quinault Pride Seafood***Net Wt. 6 oz***Ingredients: Sturgeon, salt added. The Quinault Pride brand product is labeled in part: "***SMOKED STURGEON***Quinault Pride ***Net Wt. 6 oz***Ingredients: Sturgeon, salt added. Recall # F-1443-2011
CODE
1) All codes including CQ0331078F. Code Interpretation for CQ0331078F: CQ: Canned Quinault;
 
2) All codes and including CQ0203369E; CQ0203369F; CQ0203379E, and CQ0203379F;  
 
3) All codes including CQ0240028D, CQ0240028E, CQ0240658F, CQ0240788F, CQ0241348F, CQ0241588F, CQ0240369E, CQ0240369F, CQ0240709F, CQ0240709E, CQ024211D0, CQ024211E0, CQ0241148F, and CQ0240289F;
 
4), 5), and 6) All codes;
 
7) All codes including CQ0270491G, CQ0270491D, CQ0272250E, CQ0272409B, CQ0270359E, CQ0270219F, CQ0270388E, CQ0273500E, CQ0403500E, CQ0403500G, CQ0272600E, and CQ0272590E;
 
8) All codes including CQ0203179E, CQ0200220E, CQ0200751B, CQ0200751C, and CQ0233440E;
 
9) All codes including CQ0400079E, CQ0400079F, CQ0400279E, CQ0400279A, CQ0400859A, CQ0400859B, CQ0400979B, CQ0401159B, CQ0401209A, CQ0401209B, CQ04030109B, CQ04030109C, CQ0403159D, CQ0403159E, CQ0400500E, CQ0400500F, CQ0400580F, CQ0400580E, CQ0400980F, CQ0401130F, CQ0401130E, CQ0401260C, CQ0401260B, CQ0402020D, CQ0402030D, CQ0403540G, CQ0403560G, CQ0400901C, CQ0400901D, CQ0400901E, and CQ0400229F;
 
10) All codes including CQ0401040F, CQ0400911D, and CQ0400911C;
 
11) All codes including CQ0273430E, CQ0233430E, CQ0281218F;
 
12) All codes including CQ0101180E, CQ0101180D, CQ0101180C, CQ0101380B, CQ0101380A, and CQ0101380D;
 
13) All codes including CQ0110608E and CQ0110608F;
 
14) All codes including CQ0260318E, CQ0260538E, CQ0260309F, CQ0260309E, CQ0262269B, CQ0263509E, CQ0261090F, CQ0261440D, CQ0261670D, CQ0262020D, CQ0260621D, CQ0260621B, and CQ0260631B
RECALLING FIRM/MANUFACTURER
Quinault Tribal Enterprise, Taholah, WA, by Press Release on April 29, 2011 and by telephone on May 1, 2011. Firm initiated recall is ongoing.
REASON
Canned Seafood Products were not adequately processed and observed with severe looseness of the can double seam.
VOLUME OF PRODUCT IN COMMERCE
Approx 27,705 cans
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Stewart's Ice Cream Bees Knees packaged in dip size 3 gallon box. Recall # F-1444-2011;
 
2) Stewart's Ice Cream Black Cherry packaged in pints - sleeves of 9. Recall # F-1445-2011;
 
3) Stewart's Ice Cream Black Raspberry packaged in dip size a) 3 gallon box and b) 2 quart containers - Basket of 8. Recall # F-1446-2011;
 
4) Stewart's Ice Cream Candy Cookie packaged in dip size 3 gallon box. Recall # F-1447-2011;
 
5) Stewart's Ice Cream Chocolate packaged in dip size a) 3 gallon box and b) 2 quart containers - Basket of 8. Recall # F-1448-2011;
 
6) Stewart's Ice Cream Chocolate Marshmallow packaged in 2 quart containers - Basket of 8. Recall # F-1449-2011;
 
7) Stewart's Ice Cream Chocolate Peanut Butter Cup packaged in a) pints-sleeves of 9, dip size b) 3 gallon box, and c) 2 quart containers - Basket of 8. Recall # F-1450-2011;
 
8) Stewart's Ice Cream Chocolate Trifecta packaged in 2 quart containers - Basket of 8. Recall # F-1451-2011;
 
9) Stewart's Ice Cream Coffee packaged in dip size 3 gallon box. Recall # F-1452-2011;
 
10) Stewart's Ice Cream Cookie Dough packaged in pints - sleeves of 9. Recall # F-1453-2011;
 
11) Stewart's Ice Cream Cookie Whirled packaged in dip size 3 gallon box. Recall # F-1454-2011;
 
12) Stewart's Ice Cream Crumbs Along the Mohawk packaged in a) pints - sleeves of 9, dip size b) 3 gallon box, and c) 2 quart containers - basket of 8. Recall # F-1455-2011;
 
13) Stewart's Ice Cream Dark Chocolate packaged in pints - sleeves of 9. 
Recall # F-1456-2011;
 
14) Stewart's Ice Cream Death by Chocolate packaged in dip size 3 gallon box and 2 quart containers - basket of 8. Recall # F-1457-2011;
 
15) Stewart's Ice Cream Mint Cookie Crumble packaged in dip size a) 3 gallon box and b) 2 quart containers - basket of 8. Recall # F-1458-2011;
 
16) Stewart's Ice Cream Mint Chip packaged in dip size a) 3 gallon box and b) 2 quart containers - basket of 8. Recall # F-1459-2011;
 
17) Stewart's Ice Cream Monkey Business packaged in pints - sleeves of 9. Recall # F-1460-2011;
 
18) Stewart's Ice Cream Mousse Trail packaged in pints - sleeves of 9. Recall # F-1461-2011;
 
19) Stewart's Ice Cream Mud Season packaged in dip size 3 gallon box. Recall # F-1462-2011;
 
20) Stewart's Ice Cream Peanut Butter Pandemonium packaged in dip size a) 3 gallon box and b) 2 quart containers - basket of 8. Recall # F-1463-2011;
 
21) Stewart's Ice Cream Philly Vanilla packaged in a) pints - sleeves of 9, dip size b) 3 gallon box, and c) 2 quart containers - basket of 8. Recall F-1464-2011;
 
22) Stewart's Rainbow Sherbet packaged in dip size a) 3 gallon box and b) 2 quart containers - basket of 8. Recall # F-1465-2011;
 
23) Stewart's Ice Cream Raspberry Fudge Torte packaged in dip size 3 gallon box. Recall # F-1466-2011;
 
24) Stewart's Ice Cream Vanilla packaged in dip size 3 gallon box. Recall # F-1467-2011;
 
25) Stewart's Ice Cream Vanilla - Chocolate packaged in 2 quart containers - basket of 8. Recall # F-1468-2011;
 
26) Stewart's Ice Cream No Sugar Added Reduced Fat Vanilla packaged in pints - sleeves of 9. Recall # F-1469-2011
CODE
1) code date 5/18/2011;
2) code date 1144;
3) a) code date 5/26/11; b) code date 1146;
4) code date 5/16/11;
5) a) code date 5/23/11; b) code date 1143;
6) code date 1143;
7) a) code date 1146; b) code date 5/19/11, and c) code date 1139;
8) code date 1140;
9) code date: 5/18/11;
10) code date: 1144;
11) code date 5/17/11;
12) a) code date 1138, b) code date 5/17/11 and c) code date 5/17/11;
13) code date 1136;
14) a) code box date 5/25/11, and b) code date 1145;
15) a) code date 5/24/11 and b) code date 1144;
16) a) code date 5/17/11 and b) code date 1137;
17) 1146;
18) 1146;
19) 5/19/11;
20) a) code date 5/19/11 and b) code date 1139;
21) a) code date 1138, b) code date 5/26/11, and c) code date 1146;
22) a) 5/20/11 and 5/25/11, and b) 1140 and 1145;
23) 5/25/11;
24) 5/24/11;
25) 5/18/11;
26)1136;
RECALLING FIRM/MANUFACTURER
Stewarts Processing Corp., Saratoga Springs, NY, by press release on May 27, 2011. Firm initiated recall is ongoing.
REASON
An equipment failure at the plant resulting in the possibility of foreign material being present in the ice cream.
VOLUME OF PRODUCT IN COMMERCE
1) 877 units;
2) 7,875 units;
3) a) 306 units; b) 4,752 units;
4) 811 units;
5) a) 654 units; b) 9,264 units;
6) 10,336 units;
7) a) 11,628 units; b) 467 units; c)11,824 units;
8) 10,520 units;
9) 683 units;
10) 12,330 units;
11) 884 units
12) a) 11,394 units; b) 260 units; c) 8,112 units;
13) 11,970 units;
14) a) 675 units; b) 8,192 units;
15) a) 520 units; b) 7,504 units;
16) a) 671 units; b) 9,520 units;
17) 5,967 units;
18) 6,894 units;
19) 417 units;
20) a) 45 units; b) 8,928 units;
21) a) 7,812 units; b) 88 units; c) 9,624 units;
22) a) 301 units and 225 units; b) 6704 units and 6,296 units;
23) 459 units;
24) 1,273 units;
25) 6,896 units;
26) 8,469 units
DISTRIBUTION
NY, VT
___________________________________
PRODUCT
1) Nazareth Classic, Product of Belgium. Product comes in bulk (2 loafs 6-7 lbs per case). Recall # F-1470-2011;
 
2) Nazareth Light, Product of Belgium; Serving Size - 1 slice (28 g). Product comes in bulk (2 loafs 6-7 lbs per case). Recall # F-1471-2011
CODE
1) Lots 5030009, 5030008, 10840120, 11350045, 11350044, and 11350046;
 
2) Lots 5030009, 5030008, 10840120, 11350044, 11350045, and 11350046; Expiration dates 3/13/2011-7/29/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atalanta Corp., Elizabeth, NJ, by letter on May 11, 2011 and by press release on May 20, 2011.
Manufacturer: Belgomilk Moorslede, Moorslede, Belgium. Firm initiated recall is ongoing.
REASON
Cheese may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
69 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Irwin Naturals System-Six, 100 capsule bottle, UPC Code: 7-1036326247-1, Item # IN057383. Recall # F-1491-2011
CODE
Lot #S0K052
RECALLING FIRM/MANUFACTURER
Recalling Firm: Irwin Naturals, Los Angeles, CA, by letter on June 3, 2011.
Manufacturer: Robinson Pharma, Inc., Santa Anna, CA. Firm initiated recall is ongoing.
REASON
The product is mislabeled and may contain trace amounts of allergens derived from fish oil (specifically, anchovy and/or sardine oil) which is not disclosed on the label.
VOLUME OF PRODUCT IN COMMERCE
11,974 bottles
DISTRIBUTION
Nationwide and Trinidad
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
The Best Enhancer capsules, 150 mg, 1-count blister packs packaged in a 24-count display carton and 12-count bottles, UPC 8 47046 00283 0. Recall # D-591-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: AVNS Inc. Distribution, Paramount, CA, by press release on March 28, 2011 and by letters on April 06, 2011 and on April 15, 2011.
Manufacture: Planet Advertising Group Inc. DBA Drive Total Energy, San Diego, CA. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: FDA lab analysis found that The Best Enhancer supplement contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
22,116 single blister packs and 418 12-count bottles
DISTRIBUTION
Nationwide, Australia, and Canada
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Lorazepam Injection, USP, 2 mg/mL, iSecure Syringe, Single-dose Sterile Cartridge Unit with Luer Lock, 10/1-ml. syringes per carton, 10 cartons per shipping container, For IM or IV Use, C IV, RX, NDC 0409-1985-05. Recall # D-580-2011
CODE
Lot 79-690-LL, exp. 01 JUL 2011; Lot 83-606-LL, exp. 01 NOV 2011; and Lot 91-660-LL, exp. 01 JUL 2012
RECALLING FIRM/MANUFACTURER
Hospira Inc., McPherson, KS, letters dated March 9, 2011 and emails on March 10, 2011. Firm initiated recall is ongoing.
REASON
Labeling; shipping container is labeled incorrectly with two different storing instructions.
VOLUME OF PRODUCT IN COMMERCE
242,000 syringes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
EZ-OX Plus, Oxygen Compressed USP, UN1072, Rx Only. Recall # D-581-2011
CODE
Lot numbers: 119HOS1019A and 123HOS1018A
RECALLING FIRM/MANUFACTURER
American Air Liquide Holdings, Inc., Houston, TX, by telephone and letters on May 16, 2011. Firm initiated recall is ongoing.
REASON
Container Leakage: Recalled cylinders had the potential for product leakage.
VOLUME OF PRODUCT IN COMMERCE
189 cylinders
DISTRIBUTION
TX
___________________________________
PRODUCT
1) AVALIDE (irbersartan-hydrochlorothiazide) Tablets 300/12.5 mg; NDC No: 0087-2776-31 and 0087-2776-32. Recall # D-582-2011;
 
2) AVALIDE (irbersartan-hydrochlorothiazide) Tablets 300/12.5 mg; NDC No: 0087-2776-31 and 0087-2776-32. Recall # D-583-2011;
 
3) AVALIDE (irbersartan-hydrochlorothiazide) Tablets 300/25 mg; NDC No: 0087-2788-31 and 0087-2788-32. Recall # D-584-2011  
CODE
1) Lot 9D43939A, Exp.04/12; Lot 9D43940A, Exp. 04/12; Lot 8B2028A ,Exp. 02/11; Lot 8F2029A, Exp.06/11;
 
2) Lot 9H2050A, Exp. 08/12; Lot 9D43942A, Exp. 04/12; Lot 0D61194A, Exp. 05/13; Lot 0E62452A, Exp. 05/13; Lot 0E62454A, Exp. 06/13; Lot 0E62458A, Exp. 06/13; Lot 0E62459A, Exp. 06/13; Lot 0E62464A, Exp. 06/13; Lot 9L2082A, Exp. 11/12; Lot 9D43943A, Exp 04/12; Lot 0E62455A, Exp. 06/13; Lot 0E62460A, Exp. 06/13; Lot 0E62461A, Exp. 06/13; Lot 0F61157A, Exp. 06/13; Lot 0F61158A, Exp 06/13;
 
3) Lot 9L49620A, Exp.11/12; Lot 9L49621A, Exp.11/11; Lot 9L49623A, Exp. 11/11; Lot 9L49628A, Exp.11/11; Lot 9L49629A, Exp. 11/11; Lot 9L49630A, Exp.11/11; Lot 9L49632A, Exp. 11/11; Lot 9L49633A, Exp 11/11; Lot 9L49641A, Exp. 12/11; Lot 0A57264A, Exp. 01/12; Lot 0A57265A , Exp. 01/12; Lot 0A57266A, Exp. 01/12; Lot 0A57267A, Exp. 01/12; Lot 0A57271A, Exp. 01/12; Lot 0C65450A, Exp. 03/12; Lot 0C65451A, Exp. 03/12; Lot 0C65454B, Exp. 03/12; Lot 0C65462A, Exp. 03/12; Lot 0C65464A , Exp. 03/12; Lot 0C65466A, 04/12; Lot 0C65467A, Exp. 04/12; Lot 0E57188A, Exp. 05/12; Lot 0E57189A, Exp. 05/12; Lot 0E57193A, Exp. 06/12; Lot 0F62352A, Exp. 06/12; Lot 0F62353A, Exp. 06/12; Lot 9L49625A, Exp. 11/11; Lot 9L49631A, Exp. 11/11; Lot 9L49635A, Exp. 11/11; Lot 9L49637A, Exp. 12/11; Lot 9L49638A, Exp. 12/11; Lot 0A57260A, Exp. 01/12; Lot 0A57268A, Exp. 01/12; Lot 0A57269A, Exp. 01/12; Lot 0C65449A, Exp. 03/12; Lot 0C65452A, Exp. 03/12 Lot 0C65460A, Exp. 03/12; Lot 0C65461A, Exp. 03/12; Lot 0C65463A, Exp.03/12; Lot OE57193A, Exp. 05/12; Lot 0E57194A, Exp. 06/12; Lot 0F57374A, Exp. 06/12; Lot 0F62351A, Exp. 06/12 SAMPLE LOTS Lot 9K55218A, Exp. 10/11; Lot 9L49616B, Exp. 11/11; Lot 0A57272A, Exp. 01/12;
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Manufacturing Co., Humacao, PR, by letters on December 20, 2010. Firm initiated recall is complete.
REASON
cGMP deviations: crystallization. This voluntary recall is based upon Bristol-Myers Squibbs determination that tablets from AVALIDE 150/12.5 mg, 300/12.5 mg and 300/25 mg lots manufactured by Bristol-Myers Squibb may contain small quantities of the less-soluble crystalline Form B of the irbesartan active ingredient. Crystalline Form A is the intended form of irbesartan in the finished drug product. While all lots released to the market conformed with dissolution specifications, the presence of Form B of the irbesartan crystalline structure may result in slower dissolution. A thorough review of the global post-marketing safety database has not revealed evidence of a signal suggesting reduced efficacy. However, we cannot definitively exclude this possibility at this time.
VOLUME OF PRODUCT IN COMMERCE
1,495,124 bottles and 324,792 sample packs
DISTRIBUTION
Canada, Mexico and Argentina
___________________________________
PRODUCT
Methylprednisolone Tablets USP, 4 mg, a) 21-count blister pack (NDC 0555-0301-38), b) 100-count bottle (NDC 0555-0301-02), Rx only. Recall # D-586-2011
CODE
Lot # a) 313026, 313526, 314411, 313161, 313784, 314412, Exp 4/2011; 307956, 308308, 308963, Exp 8/11; 310370, 310479, Exp 10/11; 311211, 312074, 311263, 312293, Exp 2/12; 314524, 315734, Exp 5/12; 316926, 317387, Exp 7/12; b) 309686, Exp 10/2011; 312821, 702008, Exp 2/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 10, 2011.
Manufacturer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Product; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life.
VOLUME OF PRODUCT IN COMMERCE
1,745,836 bottles & blister packs
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Global, NDC 0115-0533-01, Fenofibrate Capsules (Micronized) 200 mg; Rx Only, 100 capsules. Product of Taiwan. Recall # D-579-2011
CODE
Lot T0010061, Exp. 01/12; Lot T0020021, Exp. 01/12; Lot T0060021, Exp. 05/12; Lot T0060031, Exp. 05/12; and Lot T0060041, Exp. 05/12; Lot T0060151, Exp 5/12
RECALLING FIRM/MANUFACTURER
Impax Laboratories, Hayward, CA, by letters on March 14, 2010. Firm initiated recall is complete.
REASON
A low fill-weight tablet was found during routine quality control testing of Fenofibrate Capsules, Micronized (200 mg).
VOLUME OF PRODUCT IN COMMERCE
17,253 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Actavis Desipramine Hydrochloride Tablets USP 100 mg, 100 count, Rx only, NDC 52152-345-02, Actavis Desipramine Hydrochloride Tablets USP 150 mg, 50 count, Rx only, NDC 52152-346-50. Recall # D-585-2011
CODE
Lot # ME101222 exp 12/2013; Lot # ME101223 exp 12/2013
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, letters dated March 17, 2011. Firm initiated recall is ongoing.
REASON
Label mix-up; Package outsert states that the bottle has a child resistant closure where the actual bottles do not have a child resistant closure.
VOLUME OF PRODUCT IN COMMERCE
1,212 bottles
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
Carbamazepine Tablets USP, 200 mg, Rx only, 1000 Tablets bottle, NDC 51672-4005-3. Recall # D-587-2011
CODE
Lots 094038 exp. date 10/2012 and 094039 exp. date 10/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letters dated April 6, 2011.
Manufacturer: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: The firm is recalling these lots because of an out-of specification (OOS) dissolution results.
VOLUME OF PRODUCT IN COMMERCE
3,883 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tri-Luma Cream (fluocinolone acetonide 0.01% hydroquinone 4%, tretinoin 0.05%) Rx Only, NDC 0299-5950-30, Net Wt. 30 g GALDERMA. For External Use Only. Not for Ophthalmic Use. Usual dosage: Apply a thin film to affected areas once daily at night. See package insert for complete prescribing information. Each gram contains: Active: fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Recall # D-588-2011
CODE
Lots: D090085, D090085-1, D090085-11, D090085-111, G090122, G090122-1, G090122-11, G090122-111, H090150, H090150-2, H090150-3, H090150-4, H090150-5, E100046, E10046-2, E100046-3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galderma Laboratories, L.P., Fort Worth, TX, by letter on March 25, 2011.
Manufacturer: Hill Dermaceuticals, Inc., Sanford, FL. Firm initiated recall is complete.
REASON
The cream has the potential to be subpotent for one of the active ingredients: fluocinolone acetomide.
VOLUME OF PRODUCT IN COMMERCE
65,784 units
DISTRIBUTION
Nationwide, Aruba, Bahamas, Curacao, Jamaica, New Zealand, and Trinidad
___________________________________
PRODUCT
Antibacterial (benzalkonium chloride 0.13%) wipes/towelettes, 1-count wipe per pouch, packaged in 24-count, 30-count, and 48-count pouches per box, OTC, distributed under the following labels: a) CVS pharmacy brand, Antibacterial Moist Wipes, 1-count individually wrapped thick moist wipe per pouch, Item # H21130: 30-count pouches per box, Item # H21131, 18 boxes per case; b) Duane Reade brand, Antibacterial Wipes, Item # H26024: 1-count wipe per pouch, 24-count pouches per box; 12 boxes per case; c) W (Walgreens) brand, Ultra Anti-bacterial Towelettes, Item # D50748: 1-count wipe per pouch, 48-count pouches per box; 12 boxes per case; d) Walgreens brand, Antibacterial Thick Moist Wipes, Item # D23748: 1-count wipe per pouch, 48-count pouches per box; 12 boxes per case; e) Nice'n Clean brand, Antibacterial Moist Wipes, Item # D40812: 1-count individually wrapped wipe per pouch, 24-count pouches per box; 12 boxes per case. Recall # D-593-2011
CODE
a) Lots 900019757, Exp 9/11; 900020111, 900020112, Exp 10/11; 10900758, 10900815, 10900816, Exp 12/11; 11003447, 11003448, Exp 12/12; Lot 9E305KCP, Exp 5/11; b) Lots 900018555, Exp 09/11; 900022255, Exp 10/11; c) Lots 11000030, Exp 01/12; 11000031, 11000334, 11000406, 11000407, 11000415, Exp 02/12; d) Lots 900017839, 900017840, 900018387, 900018388, 900018389, 900018938, 900018940, Exp 09/11; 900018939, 900018941, 900020531, 900020532, Exp 10/11; 9D062BC1, Exp 03/11; 9F058BC1, 9F135BCF, 9F135BC1, 9F252BCF, Exp 05/11; 10900537, Exp 11/11; e) Lot 900022444, Exp 10/11
RECALLING FIRM/MANUFACTURER
Professional Disposables International, Inc., Orangeburg, NY, by telephone and letters on February 24, 2011 and February 25, 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: the level of the active ingredient, benzalkonium chloride, was found to be less than the label claim declaration of 0.13%.
VOLUME OF PRODUCT IN COMMERCE
19,114 cases
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1417-11
CODE
Unit: FM55966
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on July 15, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1420-11
CODE
Units: 012LE27662; 012FN27359
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated February 28, 2008.
Manufacturer: American Red Cross Blood Services, Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1424-11
CODE
Units: T22947, T17615
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated March 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel through malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1462-11
CODE
Unit: W115908051239
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail on August 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1464-11
CODE
Unit: W03551196261550
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by facsimile on April 5, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1465-11
CODE
Unit: W045010134839
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter on March 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1468-11
CODE
Units: 084FT41456; 084FT43321
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by facsimile on April 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1469-11
CODE
Unit: W038510384108
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on April 20, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1471-11
CODE
Unit: W068510371474
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile and letter on March 29, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1472-11
CODE
Units: 11631176768000; 11631176768000L; 1163117676800
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone on April 15, 2011 and follow up facsimile on May 06, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1477-11
CODE
Unit: W038111041008
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter and telephone on March 18, 2011.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1480-11
CODE
Units: 2160031514; 2160030751; 2160030407; 2160030075
RECALLING FIRM/MANUFACTURER
Plasmacare Inc., Cleveland, OH, by electronic mail on March 17, 2011. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1481-11
CODE
Unit: W037911556853
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on April 8, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1483-11
CODE
Unit: W128708066766
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on April 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1484-11;
CODE
Unit: W128709017222
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and fax on November 11, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1485-11
CODE
Unit: W128708062148
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on September 17, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1486-11
CODE
Unit: W128708061914
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and letter on September 17, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1487-11
CODE
Unit: K23479
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and fax on December 18, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
VistA Blood Establishment Computer Software (VBECS) version 1.0. Recall # B-1496-11
CODE
Unit: VBECS v1.0
RECALLING FIRM/MANUFACTURER
Dept Of Veterans Affairs Office Of Information & Technology, Hines, IL, by letter on March 17, 2010. Firm initiated recall is complete.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
86 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-1500-11
CODE
Unit: 032KX43335
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile and letter on June 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who's medical history was not properly evaluated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1501-11
CODE
Unit: LE97647
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1505-11;
2) Recovered Plasma. Recall # B-1506-11
CODE
1) and 2) Unit: LV46349
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated November 2, 2006 or by electronic notification on November 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1393-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1394-11
CODE
1) and 2) Unit: K16027
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on May 22, 2007 and by letter dated July 6, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1419-11
CODE
Units: 012LE27662; 012FN27359
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated February 28, 2008.
Manufacturer: American Red Cross Blood Services, Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1457-11
CODE
Units: GF34725, LE98386
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on February 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-1458-11
CODE
Units: FM51280, FM52439, FM52450, FM52460, FM52470
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on May 25, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1466-11
CODE
Units: W036311343037 (part 1); W036311343037 (part 2); W036311343037 (part 3); W036311343037 (part 4); W036311343037 (part 5); W036311343037 (part 6); W036311343037 (part 7); W036311343037 (part 8); W036311343037 (part 9)
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on March 25, 2011. 
Manufacturer: BloodCenter of Wisconsin, Inc., Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood products, collected in expired blood collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1467-11
CODE
Units: 11631074172300N (part 1);11631074172300N (part 2)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone and facsimile on April 6, 2011. Firm initiated recall is complete.
REASON
Blood products, prepared without the appropriate amount of additive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1470-11
CODE
Unit: 49LE14591
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by electronic mail on March 21, 2011.
Manufacturer: American Red Cross Blood Services- SW Region, Waco, TX. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1473-11
CODE
Unit: 4580106597
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., North Charleston, SC, by facsimile on April 8, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1478-11
2) Recovered Plasma. Recall # B-1479-2011
CODE
1) and 2) Unit: W036511030757
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by facsimile on March 8, 2011 and electronically on March 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, LA
_______________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1482-11
CODE
Unit: W036511024349
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by visit on January 26, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Nexgen Complete Knee Solution Femoral and Provisional Impactor/Extractor, Nonsterile, REF 00-5901-026-00. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-2173-2011;
 
2) Nexgen Complete Knee Solution Femoral Replacement Jaw for use with Femoral and Provisional Impactor/Extractor, Nonsterile, REF 00-5901-026-40. Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-2174-2011
CODE
1) Units: 61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596 61675231, 61691488, 61701224 and 61708918;
 
2) Units: 6154826, 61645115 and 61690174
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated March 14, 2011. Firm initiated recall is ongoing.
REASON
The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.
VOLUME OF PRODUCT IN COMMERCE
829 units
DISTRIBUTION
Nationwide and Australia, Canada, China, Germany, India, Japan, Singapore and Sweden
_______________________________________
PRODUCT
1) CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog 500AVHCT. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2185-2011;
 
2) CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module and Hematocrit/Saturation probe, Catalog 500AHCT. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2186-2011;
 
3) CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules, Catalog 500AV. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. Recall # Z-2187-2011;
 
4) CDI Blood Parameter Monitoring System 500 with Arterial Blood parameter module Catalog number 500A. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone system that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters. Recall # Z-2188-2011;
 
5) CDI Blood Parameter Monitoring System 500 with Venous Blood parameter module Catalog number 500V. The CDI 500 is indicated for use to display patient blood gas values during extracorporeal procedures. The CDI 500 system is a stand alone system that is used during extracorporeal procedures to continuously monitor the blood in the extracorporeal circuit, providing ongoing information about the blood parameters. Recall # Z-2189-2011
CODE
1) Units: 1005, 1011, 1013, 1014, 1016, 1017, 1018, 1019, 1020, 1021, 1024, 1032, 1036, 1039, 1041, 1043, 1044, 1047, 1049, 1050, 1051, 1052, 1053, 1059, 1063, 1066, 1067, 1068, 1069, 1070, 1071, 1075, 1096, 1101, 1102, 1103, 1104, 1105, 1111, 1112, 1113, 1115, 1129, 1130, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1166, 1167, 1168, 1181, 1182, 1183, 1184, 1216, 1217, 1218, 1219, 1220, 1231, 1232, 1233, 1234, 1235, 1245, 1246, 1247, 1248, 1254, 1255, 1261, 1262, 1263, 1264, 1270, 1271, 1272, 1273, 1274, 1285, 1286, 1287, 1288, 1289, 1295, 1296, 1297, 1298, 1299, 1305, 1306, 1307, 1308, 1309, 1312, 1313, 1314, 1315, 1321, 1332, 1333, 1334, 1340, 1341, 1342, 1344, 1350, 1352, 1353, 1354, 1357, 1358, 1379, 1380, 1383, 1389, 1390, 1391, 1392, 1393, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1408, 1414, 1415, 1416, 1418, 1421, 1422, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1439, 1440, 1441, 1442, 1443, 1450, 1451, 1452, 1453, 1460, 1461, 1462, 1479, 1480, 1554, 1597, 1599, 1601, 1605, 1617, 1618, 1619, 1620, 1621, 1622, 1623, 1624, 1625, 1626, 1627, 1628, 1629, 1630, 1631, 1637, 1638, 1639, 1640, 1641, 1642, 1643, 1644, 1645, 1646, 1657, 1658, 1659, 1660, 1661, 1672, 1673, 1674, 1675, 1682, 1683, 1684, 1685, 1686, 1697, 1698, 1699, 1700, 1701, 1712, 1713, 1714, 1715, 1716, 1733, 1734, 1736, 1737, 1787, 1788, 1789, 1805, 1806, 1807, 1808, 1809, 1815, 1816, 1817, 1818, 1819, 1830, 1844, 1845, 1846, 1857, 1858, 1859, 1860, 1886, 1887, 1888, 1889, 1890, 1901, 1902, 1903, 1904, 1905, 1916, 1917, 1918, 1919, 1920, 1926, 1927, 1928, 1929, 1930, 1936, 1937, 1938, 1939, 1940, 1953, 1954, 1955, 1956, 1957, 1958, 1959, 1960, 1961, 1962, 1963, 1964, 1965, 1966, 1967, 1968, 1969, 1970, 1971, 1972, 1973, 1974, 1977, 1978, 1979, 1980, 1981, 1982, 1983, 1984, 1985, 2029, 2030, 2031, 2032, 2033, 2034, 2036, 2037, 2038, 2040, 2045, 2059, 2060, 2061, 2062, 2063, 2065, 2066, 2067, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2086, 2097, 2098, 2099, 2100, 2101, 2109, 2110, 2111, 2113, 2114, 2115, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2130, 2131, 2138, 2139, 2140, 2141, 2142, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2177, 2178, 2179, 2180, 2181, 2182, 2185, 2186, 2187, 2189, 2195, 2196, 2197, 2198, 2199, 2214, 2216, 2217, 2218, 2219, 2224, 2228, 2229, 2230, 2231, 2243, 2244, 2245, 2249, 2250, 2251, 2252, 2253, 2255, 2256, 2257, 2258, 2260, 2263, 2265, 2266, 2267, 2268, 2275, 2276, 2277, 2279, 2285, 2286, 2287, 2288, 2289, 2290, 2291, 2295, 2296, 2297, 2298, 2313, 2314, 2315, 2316, 2317, 2318, 2319, 2320, 2321, 2323, 2324, 2325, 2326, 2327, 2328, 2329, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2346, 2347, 2348, 2348, 2349, 2349, 2350, 2350, 2351, 2351, 2352, 2352, 2354, 2357, 2368, 2370, 2371, 2372, 2373, 2374, 2375, 2377, 2392, 2403, 2404, 2405, 2406, 2407, 2408, 2417, 2418, 2419, 2420, 2421, 2422, 2423, 2424, 2425, 2426, 2432, 2433, 2434, 2435, 2436, 2439, 2440, 2441, 2442, 2443, 2444, 2453, 2454, 2455, 2456, 2457, 2458, 2463, 2464, 2465, 2466, 2467, 2470, 2471, 2472, 2476, 2477, 2478, 2479, 2480, 2481, 2482, 2483, 2487, 2488, 2489, 2490, 2491, 2492, 2493, 2494, 2495, 2496, 2497, 2498, 2499, 2500, 2501, 2502, 2503, 2514, 2515, 2516, 2517, 2521, 2522, 2523, 2524, 2525, 2541, 2542, 2543, 2544, 2545, 2546, 2547, 2548, 2549, 2550, 2551, 2552, 2553, 2554, 2555, 2556, 2565, 2566, 2567, 2568, 2569, 2570, 2571, 2572, 2573, 2574, 2575, 2576, 2577, 2578, 2579, 2580, 2581, 2582, 2587, 2588, 2589, 2590, 2591, 2592, 2593, 2594, 2595, 2596, 2597, 2598, 2599, 2600, 2601, 2602, 2603, 2629, 2630, 2631, 2632, 2633, 2635, 2636, 2637, 2638, 2639, 2640, 2641, 2642, 2646, 2647, 2656, 2661, 2662, 2664, 2665, 2666, 2667, 2668, 2669, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2680, 2689, 2690, 2691, 2695, 2696, 2701, 2702, 2703, 2704, 2705, 2706, 2707, 2708, 2710, 2711, 2712, 2713, 2714, 2715, 2716, 2722, 2723, 2724, 2725, 2726, 2727, 2737, 2742, 2743, 2744, 2745, 2746, 2747, 2757, 2758, 2759, 2760, 2761, 2762, 2763, 2764, 2765, 2766, 2767, 2768, 2769, 2770, 2771, 2772, 2773, 2783, 2784, 2788, 2793, 2794, 2795, 2802, 2805, 2806, 2807, 2808, 2815, 2816, 2817, 2818, 2819, 2820, 2837, 2838, 2839, 2846, 2847, 2848, 2849, 2865, 2866, 2867, 2868, 2869, 2870, 2880, 2881, 2882, 2883, 2884, 2885, 2886, 2887, 2888, 2889, 2892, 2893, 2894, 2895, 2906, 2907, 2908, 2913, 2914, 2915, 2920, 2921, 2924, 2925, 2926, 2937, 2938, 2939, 2940, 2942, 2943, 2944, 2945, 2946, 2947, 2952, 2958, 2959, 2960, 2961, 2962, 2963, 2964, 2965, 2966, 2967, 2968, 2969, 2970, 2971, 2972, 2973, 2974, 2975, 2979, 2980, 2981, 2982, 2983, 2990, 2991, 2992, 2993, 2994, 2995, 2996, 2997, 2998, 2999, 3008, 3009, 3010, 3022, 3023, 3024, 3025, 3026, 3027, 3040, 3041, 3052, 3053, 3054, 3055, 3073, 3074, 3075, 3083, 3084, 3085, 3086, 3087, 3096, 3115, 3116, 3139, 3140, 3141, 3142, 3143, 3144, 3145, 3152, 3153, 3155, 3156, 3157, 3158, 3159, 3160, 3161, 3162, 3169, 3170, 3171, 3172, 3173, 3174, 3175, 3176, 3177, 3178, 3179, 3180, 3181, 3182, 3190, 3191, 3192, 3193, 3194, 3195, 3196, 3214, 3215, 3216, 3217, 3218, 3219, 3220, 3225, 3226, 3227, 3228, 3232, 3238, 3239, 3240, 3241, 3242, 3243, 3244, 3245, 3248, 3249, 3264, 3265, 3266, 3267, 3268, 3287, 3288, 3291, 3292, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3314, 3315, 3316, 3317, 3318, 3319, 3320, 3321, 3322, 3323, 3329, 3330, 3331, 3332, 3333, 3334, 3340, 3341, 3342, 3343, 3344, 3345, 3346, 3347, 3348, 3349, 3354, 3355, 3356, 3357, 3369, 3370, 3371, 3372, 3373, 3383, 3384, 3385, 3386, 3387, 3388, 3389, 3390, 3391, 3394, 3395, 3396, 3397, 3402, 3403, 3404, 3405, 3406, 3416, 3418, 3419, 3420, 3421, 3422, 3423, 3424, 3425, 3426, 3427, 3434, 3435, 3436, 3437, 3441, 3442, 3443, 3444, 3445, 3446, 3447, 3449, 3450, 3451, 3452, 3453, 3454, 3455, 3456, 3458, 3459, 3460, 3461, 3462, 3470, 3471, 3472, 3481, 3482, 3489, 3490, 3500, 3501, 3502, 3503, 3509, 3510, 3518, 3534, 3535, 3541, 3542, 3543, 3544, 3545, 3571, 3572, 3573, 3590, 3591, 3592, 3593, 3594, 3595, 3596, 3597, 3598, 3599, 3600, 3601, 3602, 3603, 3604, 3605, 3606, 3607, 3608, 3609, 3612, 3613, 3614, 3615, 3616, 3617, 3618, 3619, 3624, 3625, 3626, 3627, 3628, 3636, 3637, 3638, 3639, 3643, 3644, 3645, 3669, 3670, 3671, 3672, 3673, 3674, 3675, 3676, 3677, 3678, 3679, 3680, 3681, 3698, 3699, 3700, 3701, 3702, 3703, 3715, 3716, 3722, 3723, 3724, 3725, 3726, 3738, 3739, 3740, 3741, 3742, 3743, 3744, 3753, 3754, 3755, 3756, 3757, 3769, 3770, 3771, 3772, 3773, 3774, 3775, 3776, 3777, 3778, 3779, 3780, 3784, 3785, 3786, 3787, 3799, 3800, 3801, 3802, 3803, 3804, 3811, 3812, 3813, 3814, 3815, 3816, 3827, 3828, 3829, 3830, 3838, 3839, 3840, 3841, 3852, 3853, 3854, 3855, 3856, 3857, 3858, 3859, 3860, 3861, 3862, 3863, 3864, 3865, 3866, 3867, 3868, 3869, 3870, 3871, 3872, 3873, 3874, 3875, 3876, 3877, 3878, 3879, 3880, 3881, 3892, 3893, 3894, 3895, 3896, 3897, 3898, 3899, 3902, 3903, 3904, 3905, 3906, 3912, 3913, 3914, 3915, 3916, 3917, 3918, 3919, 3920, 3921, 3924, 3925, 3926, 3927, 3928, 3929, 3930, 3931, 3937, 3938, 3939, 3940, 3941, 3942, 3943, 3944, 3945, 3946, 3947, 3948, 3949, 3950, 3951, 3952, 3962, 3963, 3964, 3965, 3971, 3972, 3973, 3974, 3986, 3987, 3988, 3989, 3995, 3996, 3997, 3998, 4006, 4007, 4008, 4009, 4010, 4011, 4012, 4013, 4014, 4015, 4016, 4017, 4018, 4019, 4020, 4021, 4022, 4023, 4024, 4025, 4026, 4027, 4028, 4029, 4038, 4039, 4040, 4041, 4042, 4043, 4050, 4051, 4052, 4053, 4054, 4055, 4070, 4071, 4072, 4073, 4074, 4075, 4082, 4083, 4084, 4085, 4086, 4087, 4088, 4089, 4096, 4097, 4098, 4099, 4105, 4106, 4107, 4108, 4114, 4115, 4116, 4117, 4118, 4119, 4120, 4121, 4122, 4123, 4124, 4125, 4126, 4127, 4128, 4129, 4130, 4131, 4143, 4144, 4145, 4146, 4147, 4148, 4169, 4170, 4171, 4172, 4173, 4174, 4175, 4176, 4177, 4178, 4179, 4180, 4181, 4182, 4183, 4184, 4185, 4203, 4204, 4205, 4206, 4207, 4208, 4209, 4210, 4211, 4212, 4219, 4220, 4221, 4222, 4223, 4224, 4230, 4231, 4232, 4233, 4234, 4235, 4236, 4237, 4238, 4239, 4240, 4241, 4260, 4261, 4262, 4263, 4264, 4265, 4266, 4267, 4268, 4269, 4270, 4271, 4272, 4273, 4274, 4275, 4276, 4277, 4278, 4279, 4280, 4290, 4291, 4292, 4293, 4294, 4295, 4296, 4297, 4298, 4299, 4307, 4308, 4309, 4310, 4318, 4319, 4320, 4321, 4322, 4323, 4335, 4336, 4337, 4338, 4339, 4340, 4341, 4342, 4343, 4344, 4351 and 4352;
 
2) Units: 1023, 1025, 1026, 1027, 1029, 1030, 1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054, 1055, 1056, 1057, 1060, 1061, 1062, 1065, 1072, 1073, 1074, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1098, 1099, 1100, 1106, 1107, 1108, 1109, 1110, 1114, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1131, 1132, 1141, 1142, 1143, 1144, 1145, 1154, 1155, 1156, 1157, 1158, 1159, 1160, 1161, 1162, 1164, 1165, 1169, 1170, 1171, 1173, 1174, 1175, 1176, 1177, 1178, 1179, 1180, 1186, 1187, 1188, 1189, 1190, 1191, 1194, 1195, 1197, 1198, 1199, 1200, 1201, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1210, 1213, 1214, 1215, 1221, 1222, 1223, 1224, 1225, 1226, 1227, 1228, 1229, 1230, 1236, 1237, 1238, 1242, 1249, 1250, 1251, 1252, 1253, 1256, 1257, 1258, 1259, 1260, 1265, 1266, 1267, 1268, 1275, 1278, 1279, 1280, 1281, 1283, 1284, 1290, 1291, 1292, 1293, 1294, 1300, 1301, 1302, 1303, 1304, 1310, 1311, 1316, 1317, 1318, 1319, 1322, 1324, 1325, 1326, 1328, 1329, 1330, 1331, 1335, 1336, 1337, 1339, 1345, 1346, 1347, 1348, 1349, 1359, 1360, 1361, 1362, 1363, 1364, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1372, 1374, 1375, 1376, 1377, 1378, 1384, 1385, 1386, 1387, 1388, 1394, 1395, 1396, 1397, 1398, 1409, 1410, 1411, 1412, 1413, 1419, 1434, 1435, 1436, 1437, 1438, 1444, 1445, 1446, 1447, 1448, 1454, 1455, 1456, 1457, 1458, 1469, 1470, 1471, 1472, 1473, 1474, 1475, 1476, 1477, 1478, 1481, 1482, 1484, 1485, 1486, 1487, 1488, 1489, 1490, 1492, 1493, 1494, 1495, 1496, 1497, 1499, 1500, 1501, 1502, 1503, 1505, 1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1520, 1528, 1532, 1533, 1534, 1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1546, 1547, 1548, 1549, 1550, 1551, 1552, 1553, 1555, 1556, 1557, 1558, 1567, 1568, 1569, 1570, 1571, 1572, 1573, 1574, 1575, 1577, 1578, 1579, 1580, 1581, 1582, 1583, 1584, 1585, 1586, 1587, 1588, 1589, 1590, 1591, 1592, 1593, 1594, 1595, 1596, 1607, 1608, 1609, 1610, 1611, 1612, 1613, 1614, 1616, 1632, 1633, 1634, 1636, 1647, 1648, 1649, 1650, 1651, 1652, 1653, 1654, 1655, 1656, 1667, 1668, 1669, 1670, 1671, 1677, 1678, 1679, 1680, 1681, 1687, 1688, 1689, 1691, 1692, 1693, 1694, 1695, 1696, 1702, 1703, 1704, 1705, 1706, 1707, 1708, 1709, 1710, 1711, 1717, 1718, 1719, 1720, 1721, 1728, 1729, 1730, 1731, 1732, 1738, 1739, 1740, 1741, 1742, 1743, 1744, 1745, 1746, 1747, 1748, 1749, 1750, 1751, 1752, 1753, 1759, 1760, 1763, 1764, 1765, 1766, 1767, 1768, 1769, 1770, 1771, 1772, 1773, 1774, 1775, 1777, 1778, 1779, 1780, 1781, 1782, 1783, 1784, 1785, 1786, 1790, 1791, 1792, 1793, 1794, 1796, 1797, 1798, 1799, 1801, 1802, 1803, 1804, 1810, 1811, 1812, 1813, 1814, 1820, 1821, 1822, 1823, 1824, 1825, 1826, 1827, 1828, 1829, 1831, 1832, 1833, 1834, 1835, 1836, 1837, 1838, 1839, 1840, 1842, 1843, 1847, 1848, 1849, 1850, 1856, 1861, 1862, 1863, 1864, 1865, 1866, 1867, 1868, 1869, 1870, 1871, 1872, 1873, 1874, 1875, 1876, 1877, 1878, 1879, 1880, 1881, 1882, 1883, 1884, 1885, 1891, 1892, 1893, 1894, 1895, 1896, 1897, 1898, 1899, 1900, 1906, 1907, 1908, 1909, 1911, 1912, 1913, 1914, 1915, 1921, 1922, 1923, 1924, 1925, 1931, 1932, 1933, 1934, 1935, 1941, 1942, 1943, 1944, 1945, 1946, 1947, 1948, 1949, 1950, 1975, 1986, 1987, 1988, 1989, 1990, 1991, 1992, 1993, 1994, 1996, 1997, 1998, 1999, 2000, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2017, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2028, 2039, 2041, 2042, 2043, 2044, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2057, 2058, 2064, 2068, 2069, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2116, 2118, 2119, 2120, 2121, 2122, 2132, 2133, 2134, 2135, 2136, 2137, 2143, 2144, 2145, 2146, 2147, 2148, 2156, 2157, 2158, 2159, 2160, 2161, 2162, 2163, 2164, 2165, 2166, 2167, 2168, 2169, 2170, 2171, 2172, 2173, 2174, 2175, 2176, 2183, 2184, 2188, 2191, 2192, 2193, 2194, 2200, 2201, 2202, 2203, 2204, 2205, 2206, 2207, 2208, 2209, 2210, 2211, 2212, 2213, 2215, 2220, 2221, 2222, 2223, 2225, 2226, 2227, 2232, 2233, 2234, 2235, 2236, 2237, 2238, 2239, 2240, 2241, 2242, 2247, 2248, 2254, 2259, 2261, 2262, 2264, 2269, 2270, 2271, 2272, 2278, 2280, 2281, 2282, 2283, 2284, 2292, 2293, 2294, 2299, 2300, 2301, 2302, 2303, 2304, 2305, 2306, 2307, 2308, 2309, 2310, 2311, 2312, 2330, 2331, 2332, 2333, 2334, 2335, 2337, 2353, 2353, 2359, 2360, 2361, 2362, 2363, 2376, 2378, 2379, 2380, 2381, 2382, 2383, 2384, 2385, 2386, 2387, 2388, 2398, 2399, 2400, 2401, 2402, 2409, 2410, 2411, 2412, 2413, 2414, 2415, 2416, 2427, 2428, 2429, 2430, 2431, 2437, 2438, 2445, 2446, 2447, 2448, 2449, 2451, 2452, 2459, 2460, 2461, 2462, 2468, 2469, 2473, 2474, 2475, 2484, 2485, 2486, 2505, 2506, 2507, 2508, 2509, 2510, 2511, 2512, 2513, 2518, 2519, 2520, 2526, 2527, 2528, 2529, 2530, 2531, 2532, 2533, 2534, 2535, 2536, 2537, 2538, 2539, 2540, 2557, 2558, 2559, 2560, 2561, 2563, 2564, 2583, 2584, 2585, 2586, 2604, 2605, 2606, 2607, 2608, 2611, 2612, 2613, 2614, 2615, 2616, 2618, 2619, 2620, 2621, 2622, 2623, 2624, 2625, 2626, 2627, 2628, 2643, 2644, 2645, 2648, 2649, 2650, 2651, 2652, 2653, 2654, 2655, 2657, 2658, 2659, 2660, 2663, 2681, 2682, 2683, 2684, 2685, 2686, 2687, 2688, 2692, 2693, 2694, 2697, 2698, 2699, 2709, 2717, 2718, 2719, 2720, 2721, 2728, 2729, 2730, 2731, 2732, 2733, 2734, 2735, 2736, 2738, 2739, 2740, 2741, 2748, 2749, 2750, 2751, 2752, 2753, 2754, 2755, 2756, 2774, 2775, 2776, 2777, 2778, 2779, 2780, 2781, 2785, 2786, 2787, 2789, 2790, 2792, 2796, 2797, 2798, 2799, 2803, 2809, 2810, 2811, 2812, 2813, 2814, 2821, 2822, 2823, 2824, 2825, 2826, 2827, 2828, 2829, 2830, 2831, 2832, 2833, 2834, 2835, 2836, 2840, 2841, 2842, 2843, 2844, 2845, 2850, 2851, 2852, 2853, 2854, 2855, 2856, 2857, 2858, 2859, 2861, 2862, 2863, 2864, 2871, 2872, 2873, 2874, 2875, 2876, 2877, 2878, 2879, 2896, 2897, 2898, 2899, 2900, 2903, 2904, 2905, 2909, 2910, 2911, 2912, 2916, 2917, 2918, 2919, 2922, 2923, 2927, 2928, 2929, 2930, 2931, 2932, 2933, 2934, 2935, 2936, 2941, 2948, 2949, 2950, 2951, 2953, 2954, 2955, 2956, 2957, 2976, 2977, 2978, 2984, 2985, 2986, 2987, 2988, 2989, 3000, 3001, 3002, 3003, 3004, 3005, 3006, 3007, 3014, 3015, 3016, 3017, 3018, 3019, 3020, 3021, 3028, 3029, 3030, 3031, 3032, 3033, 3034, 3035, 3036, 3037, 3038, 3039, 3042, 3043, 3044, 3045, 3046, 3047, 3048, 3049, 3050, 3056, 3057, 3058, 3059, 3060, 3061, 3062, 3063, 3064, 3065, 3066, 3067, 3068, 3069, 3070, 3071, 3072, 3076, 3077, 3078, 3079, 3080, 3081, 3082, 3088, 3089, 3090, 3091, 3092, 3093, 3094, 3095, 3097, 3098, 3099, 3100, 3101, 3102, 3103, 3104, 3105, 3106, 3107, 3109, 3110, 3111, 3112, 3113, 3114, 3117, 3118, 3119, 3120, 3121, 3122, 3123, 3124, 3126, 3127, 3128, 3129, 3130, 3136, 3137, 3138, 3147, 3148, 3149, 3150, 3151, 3154, 3163, 3164, 3165, 3166, 3167, 3168, 3183, 3184, 3185, 3186, 3187, 3188, 3189, 3197, 3198, 3199, 3200, 3201, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3210, 3211, 3212, 3213, 3221, 3222, 3223, 3224, 3229, 3230, 3231, 3233, 3234, 3235, 3236, 3237, 3246, 3247, 3250, 3251, 3252, 3253, 3254, 3255, 3256, 3257, 3258, 3259, 3260, 3269, 3270, 3271, 3273, 3274, 3275, 3276, 3277, 3278, 3279, 3280, 3281, 3282, 3283, 3284, 3285, 3286, 3290, 3307, 3308, 3309, 3310, 3311, 3312, 3313, 3324, 3325, 3326, 3327, 3328, 3335, 3336, 3337, 3339, 3350, 3351, 3352, 3353, 3358, 3359, 3360, 3361, 3362, 3363, 3364, 3365, 3366, 3367, 3368, 3374, 3375, 3376, 3377, 3378, 3379, 3380, 3381, 3382, 3392, 3393, 3398, 3399, 3400, 3401, 3407, 3408, 3409, 3411, 3412, 3413, 3414, 3415, 3428, 3429, 3430, 3431, 3432, 3433, 3438, 3439, 3440, 3448, 3457, 3463, 3464, 3465, 3466, 3467, 3468, 3473, 3474, 3475, 3476, 3477, 3478, 3479, 3483, 3484, 3485, 3486, 3487, 3488, 3491, 3492, 3493, 3494, 3495, 3496, 3497, 3498, 3499, 3504, 3505, 3506, 3507, 3508, 3511, 3512, 3513, 3514, 3515, 3516, 3517, 3519, 3520, 3521, 3522, 3523, 3524, 3525, 3526, 3527, 3528, 3529, 3530, 3531, 3532, 3533, 3536, 3537, 3538, 3539, 3540, 3546, 3547, 3548, 3549, 3550, 3551, 3552, 3553, 3554, 3555, 3556, 3557, 3558, 3559, 3560, 3561, 3562, 3563, 3564, 3565, 3566, 3567, 3568, 3569, 3570, 3574, 3575, 3576, 3577, 3578, 3579, 3580, 3581, 3582, 3583, 3584, 3585, 3586, 3587, 3588, 3589, 3610, 3611, 3620, 3621, 3622, 3623, 3632, 3633, 3634, 3635, 3640, 3641, 3642, 3649, 3650, 3651, 3652, 3653, 3654, 3655, 3656, 3657, 3658, 3659, 3660, 3662, 3663, 3664, 3665, 3666, 3667, 3668, 3682, 3683, 3684, 3685, 3686, 3687, 3688, 3689, 3690, 3691, 3692, 3693, 3694, 3695, 3696, 3697, 3704, 3705, 3706, 3707, 3708, 3709, 3710, 3711, 3712, 3713, 3714, 3717, 3718, 3719, 3720, 3721, 3727, 3728, 3729, 3730, 3731, 3732, 3733, 3734, 3735, 3736, 3737, 3745, 3746, 3747, 3748, 3749, 3750, 3752, 3758, 3759, 3760, 3761, 3762, 3763, 3764, 3765, 3766, 3767, 3768, 3781, 3782, 3783, 3788, 3789, 3790, 3791, 3792, 3793, 3794, 3795, 3796, 3797, 3798, 3805, 3806, 3807, 3808, 3809, 3810, 3817, 3818, 3819, 3820, 3821, 3822, 3823, 3824, 3825, 3826, 3831, 3832, 3833, 3834, 3835, 3836, 3837, 3842, 3843, 3844, 3845, 3846, 3847, 3848, 3849, 3850, 3851, 3882, 3884, 3885, 3886, 3887, 3888, 3889, 3890, 3891, 3900, 3901, 3907, 3908, 3909, 3910, 3911, 3922, 3923, 3932, 3933, 3934, 3935, 3936, 3953, 3954, 3956, 3957, 3958, 3959, 3960, 3961, 3966, 3967, 3968, 3969, 3970, 3975, 3976, 3977, 3978, 3979, 3980, 3981, 3982, 3983, 3984, 3985, 3990, 3991, 3992, 3993, 3994, 3999, 4000, 4001, 4002, 4003, 4004, 4005, 4030, 4031, 4032, 4033, 4034, 4035, 4036, 4037, 4044, 4045, 4046, 4047, 4048, 4049, 4056, 4057, 4058, 4059, 4060, 4061, 4062, 4063, 4064, 4065, 4066, 4067, 4068, 4069, 4076, 4077, 4078, 4079, 4080, 4081, 4090, 4091, 4092, 4093, 4094, 4095, 4100, 4101, 4102, 4103, 4104, 4109, 4110, 4111, 4112, 4113, 4133, 4134, 4135, 4136, 4137, 4138, 4139, 4140, 4141, 4142, 4149, 4150, 4151, 4152, 4153, 4154, 4155, 4156, 4157, 4158, 4159, 4160, 4161, 4162, 4163, 4164, 4165, 4166, 4167, 4168, 4186, 4187, 4188, 4189, 4190, 4191, 4192, 4193, 4194, 4195, 4196, 4197, 4198, 4199, 4200, 4201, 4202, 4213, 4214, 4215, 4216, 4217, 4218, 4225, 4226, 4227, 4228, 4229, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4251, 4252, 4253, 4254, 4255, 4256, 4257, 4258, 4259, 4281, 4282, 4283, 4284, 4285, 4286, 4287, 4288, 4289, 4300, 4301, 4302, 4303, 4304, 4305, 4306, 4311, 4312, 4313, 4314, 4315, 4316, 4317, 4324, 4325, 4326, 4327, 4328, 4329, 4330, 4331, 4332, 4333, 4334, 4345, 4346, 4347, 4348, 4349, 4350, 4353, 4354, 4355, 4356, 4357, 4358, 4359, 4360, 4361, 4362, 4363, 4364, 4365, 4366, 4367, 4368, 4369, 4370 and 4371;
 
3) Units: 1193, 1355, 1356, 1420, 1423, 1464, 1465, 1504, 1521, 1522, 1523, 1524, 1526, 1527, 1529, 1530, 1602, 1603, 1604, 1606, 1662, 2035, 2102, 2103, 2104, 2105, 2106, 2107, 2800, 2901, 2902, 3131, 3132, 3133, 3134, 3135, 3261, 3262 and 4132;
 
4) Units: 1559, 1560, 1561, 1562, 1563, 1663, 1664, 1665, 1666, 1722, 1723, 1724, 1725, 1727, 1754, 1755, 1757, 1758, 1776, 1795, 1951, 1952, 2016, 2112, 2190, 2273, 2274, 2322, 2355, 2356, 2389, 2390, 2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011, 3012, 3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629, 3630, 3631, 3646, 3647 and 3661;
 
5) Units: 1564, 1565 and 1566
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated October 27, 2010. Firm initiated recall is ongoing.
REASON
The CDI 500 monitor may display inaccurate values. These errors include inaccurate potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other miscellaneous inaccurate values.
VOLUME OF PRODUCT IN COMMERCE
3,260 all models
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection. It is important to note that this recall does not affect or involve the Forteo Delivery Device. The starter kits did not contain the Forteo Delivery Device. Recall # Z-2191-2011
CODE
No code. Kits were distributed between March 2008 and June 2009.
RECALLING FIRM/MANUFACTURER
Eli Lilly and Company, Indianapolis, IN, by letters dated March 18, 2011 and March 28, 2011. Firm initiated recall is ongoing.
REASON
Recalling the alcohol prep pads due to potential contamination with the bacteria, Ba-cillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
VOLUME OF PRODUCT IN COMMERCE
47,000 kits
DISTRIBUTION
Nationwide and Czech Republic, Germany, Slovak Republic, and Switzerland
___________________________________
PRODUCT
Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Recall # Z-2195-2011
CODE
Serial numbers: H140001 ,H140048 ,H140095 ,H140141 ,H140232 ,H140736 H140781 H140826 ,H140871 ,H180004 ,H180108 ,H140002 ,H140049 ,H140096 ,H140142 ,H140233 H140737 ,H140782 ,H140827 ,H140872 ,H180007 ,H180115 ,H140003 ,H140051 ,H140097 H140143 ,H140234 ,H140738 ,H140783 ,H140828 ,H140873 ,H180008 ,H180116 ,H140004 H140052 ,H140098 ,H140144 ,H140235 ,H140739 ,H140784 ,H140829 ,H140874 ,H180016 H180117 ,H140005 ,H140053 ,H140099 ,H140145 ,H140236 ,H140740 ,H140785 ,H140830 H140875 ,H180017 ,H180119 ,H140006 ,H140054 ,H140100 ,H140146 ,H140237 ,H140741 H140786 ,H140831 ,H140876 ,H180019 ,H180122 ,H140007 ,H140055 ,H140101 ,H140147 H140238 ,H140742 ,H140787 ,H140832 ,H140877 ,H180025 ,H180124 ,H140008 ,H140056 H140102 ,H140148 ,H140239 ,H140743 ,H140788 ,H140833 ,H140878 ,H180026 ,H180128 H140009 ,H140057 ,H140103 ,H140149 ,H140240 ,H140744 ,H140789 ,H140834 ,H140879 H180028 ,H180129 ,H140010 ,H140058 ,H140105 ,H140150 ,H140700 ,H140745 ,H140790 H140835 ,H140881 ,H180034 ,H180131 ,H140011 ,H140059 ,H140106 ,H140151 ,H140701 H140746 ,H140791 ,H140836 ,H140882 ,H180040 ,H180132 ,H140012 ,H140060 ,H140107 H140152 ,H140702 ,H140747 ,H140792 ,H140837 ,H140883 ,H180043 ,H180133 ,H140014 H140061 ,H140108 ,H140153 ,H140703 ,H140748 ,H140793 ,H140838 ,H140884 ,H180044 H180135 ,H140015 ,H140062 ,H140109 ,H140154 ,H140704 ,H140749 ,H140794 ,H140839 H140886 ,H180045 ,H180143 ,H140016 ,H140063 ,H140110 ,H140201 ,H140705 ,H140750 H140795 ,H140840 ,H140887 ,H180048 ,H180144 ,H140017 ,H140064 ,H140111 ,H140202 H140706 ,H140751 ,H140796 ,H140841 ,H140889 ,H180049 ,H180147 ,H140018 ,H140065 H140112 ,H140203 ,H140707 ,H140752 ,H140797 ,H140842 ,H140890 ,H180050 ,H180148 H140019 ,H140066 ,H140113 ,H140204 ,H140708 ,H140753 ,H140798 ,H140843 ,H140891 H180052 ,H180151 ,H140021 ,H140067 ,H140114 ,H140205 ,H140709 ,H140754 ,H140799 H140844 ,H140892 ,H180053 ,H180154 ,H140022 ,H140068 ,H140115 ,H140206 ,H140710, H140755 ,H140800 ,H140845 ,H140893 ,H180056 ,H180157 ,H140023 ,H140069 ,H140116 H140207 ,H140711 ,H140756 ,H140801 ,H140846 ,H140895 ,H180058 ,H180158 ,H140024 H140070 ,H140117 ,H140208 ,H140712 ,H140757 ,H140802 ,H140847 ,H140896 ,H180059 H180159 ,H140025 ,H140071 ,H140118 ,H140209 ,H140713 ,H140758 ,H140803 ,H140848 H140897 ,H180062 ,H180160 ,H140026 ,H140072 ,H140119 ,H140210 ,H140714 ,H140759 H140804 ,H140849 ,H140898 ,H180065 ,H180161 ,H140027 ,H140073 ,H140120 ,H140211 H140715 ,H140760 ,H140805 ,H140850 ,H140899 ,H180066 ,H180164 ,H140028 ,H140074 H140121 ,H140212 ,H140716 ,H140761 ,H140806 ,H140851 ,H140900 ,H180067 ,H180166 H140029 ,H140075 ,H140122 ,H140213 ,H140717 ,H140762 ,H140807 ,H140852 ,H140901 H180069 ,H180167 ,H140030 ,H140076 ,H140123 ,H140214 ,H140718 ,H140763 ,H140808 H140853 ,H140902 ,H180073 ,H180168 ,H140031 ,H140077 ,H140124 ,H140215 ,H140719 H140764 ,H140809 ,H140854 ,H140903 ,H180075 ,H180170 ,H140032 ,H140078 ,H140125 H140216 ,H140720 ,H140765 ,H140810 ,H140855 ,H140904 ,H180077 ,H180171 ,H140033 H140079 ,H140126 ,H140217 ,H140721 ,H140766 ,H140811 ,H140856 ,H140905 ,H180079 H180173 ,H140034 ,H140080 ,H140127 ,H140218 ,H140722 ,H140767 ,H140812 ,H140857 H140906 ,H180080 ,H180175 ,H140035 ,H140082 ,H140128 ,H140219 ,H140723 ,H140768 H140813 ,H140858 ,H140907 ,H180082 ,H180178 ,H140036 ,H140083 ,H140129 ,H140220 H140724 ,H140769 ,H140814 ,H140859 ,H140908 ,H180083 ,H180179 ,H140037 ,H140084 H140130 ,H140221 ,H140725 ,H140770 ,H140815 ,H140860 ,H140909 ,H180087 ,H180180 H140038 ,H140085 ,H140131 ,H140222 ,H140726 ,H140771 ,H140816 ,H140861 ,H140910 H180088 ,H180181 ,H140039 ,H140086 ,H140132 ,H140223 ,H140727 ,H140772 ,H140817 H140862 ,H140911 ,H180089 ,H180182 ,H140040 ,H140087 ,H140133 ,H140224 ,H140728 H140773 ,H140818 ,H140863 ,H140912 ,H180093 ,H180185 ,H140041 ,H140088 ,H140134 H140225 ,H140729 ,H140774 ,H140819 ,H140864 ,H140913 ,H180098 ,H180186 ,H140042 H140089 ,H140135 ,H140226 ,H140730 ,H140775 ,H140820 ,H140865 ,H140914 ,H180099 H180188 ,H140043 ,H140090 ,H140136 ,H140227 ,H140731 ,H140776 ,H140821 ,H140866 H140915 ,H180102 ,H180192 ,H140044 ,H140091 ,H140137 ,H140228 ,H140732 ,H140777 H140822 ,H140867 ,H140916 ,H180103 ,H180193 ,H140045 ,H140092 ,H140138 ,H140229 H140733 ,H140778 ,H140823 ,H140868 ,H140917 ,H180104 ,H180195 ,H140046 ,H140093 H140139 ,H140230 ,H140734 ,H140779 ,H140824 ,H140869 ,H140919 ,H180106 ,H180197 H140047 ,H140094 ,H140140 ,H140231 ,H140735 ,H140780 ,H140825 ,H140870 ,H180003 H180107 ,H180199 ,H180201 ,H180283 ,H180414 ,H180476 ,H180538 ,H180590 ,H180639 H180689 ,H180739 ,H180788 ,H180839 ,H180203 ,H180284 ,H180415 ,H180477 ,H180539 H180591 ,H180640 ,H180690 ,H180740 ,H180790 ,H180840 ,H180204 ,H180285 ,H180417 H180478 ,H180540 ,H180592 ,H180641 ,H180691 ,H180741 ,H180791 ,H180841 ,H180206 H180287 ,H180419 ,H180479 ,H180541 ,H180593 ,H180642 ,H180692 ,H180742 ,H180792 H180842 ,H180208 ,H180289 ,H180420 ,H180480 ,H180542 ,H180594 ,H180643 ,H180693 H180743 ,H180793 ,H180843 ,H180209 ,H180290 ,H180422 ,H180482 ,H180543 ,H180595 H180644 ,H180694 ,H180744 ,H180794 ,H180844 ,H180210 ,H180291 ,H180424 ,H180484 H180544 ,H180596 ,H180645 ,H180695 ,H180745 ,H180795 ,H180845 ,H180214 ,H180292 H180425 ,H180485 ,H180545 ,H180597 ,H180646 ,H180696 ,H180746 ,H180796 ,H180846 H180215 ,H180293 ,H180426 ,H180486 ,H180547 ,H180598 ,H180647 ,H180697 ,H180747 H180798 ,H180847 ,H180217 ,H180294 ,H180427 ,H180487 ,H180548 ,H180599 ,H180648 H180698 ,H180748 ,H180799 ,H180848 ,H180218 ,H180295 ,H180430 ,H180489 ,H180549 H180600 ,H180649 ,H180699 ,H180749 ,H180800 ,H180849 ,H180220 ,H180296 ,H180432 H180490 ,H180550 ,H180601 ,H180650 ,H180700 ,H180750 ,H180801 ,H180850 ,H180221, H180298 ,H180433 ,H180491 ,H180551 ,H180602 ,H180651 ,H180701 ,H180751 H180802 ,H180851 ,H180222 ,H180299 ,H180436 ,H180492 ,H180552 ,H180603 ,H180652 H180702 ,H180752 ,H180803 ,H180852 ,H180225 ,H180303 ,H180437 ,H180493 ,H180553 H180604 ,H180653 ,H180703 ,H180753 ,H180804 ,H180853 ,H180226 ,H180304 ,H180440 H180494 ,H180554 ,H180605 ,H180654 ,H180704 ,H180754 ,H180805 ,H180854 ,H180228 H180305 ,H180441 ,H180495 ,H180555 ,H180606 ,H180655 ,H180705 ,H180755 ,H180806 H180855 ,H180229 ,H180307 ,H180442 ,H180496 ,H180556 ,H180607 ,H180656 ,H180706 H180756 ,H180807 ,H180856 ,H180230 ,H180309 ,H180443 ,H180498 ,H180557 ,H180608 H180657 ,H180707 ,H180757 ,H180808 ,H180857 ,H180233 ,H180310 ,H180444 ,H180499 H180559 ,H180610 ,H180658 ,H180708 ,H180758 ,H180809 ,H180858 ,H180235 ,H180311 H180445 ,H180501 ,H180560 ,H180611 ,H180659 ,H180709 ,H180759 ,H180810 ,H180859 H180236 ,H180312 ,H180446 ,H180502 ,H180561 ,H180612 ,H180660 ,H180710 ,H180760 H180811 ,H180860 ,H180237 ,H180314 ,H180447 ,H180505 ,H180562 ,H180613 ,H180661 H180711 ,H180761 ,H180812 ,H180861 ,H180238 ,H180315 ,H180449 ,H180507 ,H180563 H180614 ,H180662 ,H180713 ,H180762 ,H180813 ,H180862 ,H180239 ,H180318 ,H180450 H180508 ,H180564 ,H180615 ,H180663 ,H180714 ,H180763 ,H180814 ,H180863 ,H180240 H180319 ,H180451 ,H180509 ,H180565 ,H180616 ,H180664 ,H180715 ,H180764 ,H180815 H180864 ,H180242 ,H180321 ,H180452 ,H180510 ,H180566 ,H180617 ,H180665 ,H180716 H180765 ,H180816 ,H180865 ,H180243 ,H180322 ,H180453 ,H180511 ,H180567 ,H180618 H180667 ,H180717 ,H180766 ,H180817 ,H180866 ,H180245 ,H180323 ,H180454 ,H180513 H180569 ,H180619 ,H180668 ,H180718 ,H180767 ,H180818 ,H180867 ,H180246 ,H180324 H180455 ,H180514 ,H180570 ,H180620 ,H180669 ,H180719 ,H180768 ,H180819 ,H180868 H180249 ,H180325 ,H180456 ,H180515 ,H180571 ,H180621 ,H180670 ,H180720 ,H180769 H180820 ,H180869 ,H180250 ,H180326 ,H180457 ,H180518 ,H180572 ,H180622 ,H180671 H180721 ,H180770 ,H180821 ,H180870 ,H180251 ,H180327 ,H180458 ,H180519 ,H180573 H180623 ,H180672 ,H180722 ,H180771 ,H180822 ,H180871 ,H180254 ,H180328 ,H180459 H180520 ,H180574 ,H180624 ,H180673 ,H180723 ,H180772 ,H180823 ,H180872 ,H180255 H180329 ,H180460 ,H180521 ,H180575 ,H180625 ,H180674 ,H180724 ,H180773 ,H180824 H180873 ,H180256 ,H180330 ,H180461 ,H180522 ,H180576 ,H180626 ,H180675 ,H180725 H180774 ,H180825 ,H180874 ,H180257 ,H180401 ,H180462 ,H180524 ,H180577 ,H180627 H180676 ,H180726 ,H180775 ,H180826 ,H180875 ,H180258 ,H180402 ,H180463 ,H180525 H180578 ,H180628 ,H180678 ,H180727 ,H180776 ,H180827 ,H180876 ,H180260 ,H180403 H180466 ,H180527 ,H180579 ,H180629 ,H180679 ,H180728 ,H180777 ,H180828 ,H180877 H180262 ,H180404 ,H180467 ,H180528 ,H180580 ,H180630 ,H180680 ,H180729 ,H180778 H180829 ,H180878 ,H180264 ,H180405 ,H180468 ,H180529 ,H180581 ,H180631 ,H180681 H180730 ,H180779 ,H180830 ,H180879 ,H180267 ,H180406 ,H180469 ,H180530 ,H180582 H180632 ,H180682 ,H180731 ,H180780 ,H180831 ,H180880 ,H180268 ,H180407 ,H180470 H180531 ,H180583 ,H180633 ,H180683 ,H180733 ,H180781 ,H180832 ,H180881 ,H180270 H180409 ,H180471 ,H180532 ,H180584 ,H180634 ,H180684 ,H180734 ,H180782 ,H180833 H180882 ,H180271 ,H180410 ,H180472 ,H180533 ,H180585 ,H180635 ,H180685 ,H180735 H180783 ,H180834 ,H180883 ,H180272 ,H180411 ,H180473 ,H180534 ,H180586 ,H180636 H180686 ,H180736 ,H180784 ,H180836 ,H180884 H180273, H180412 ,H180474 ,H180535 H180587 ,H180637 ,H180687 ,H180737, H180785, H180837, H180885 ,H180275 ,H180413 H180475 ,H180536 ,H180588 ,H180638 ,H180688, H180738, ,H180786 ,H180838 ,H180886 H180887 ,H181034 ,H181083 ,H181137 ,H181196, H270216 ,H270324 ,H270420 ,H270495 H270624 ,H270698 ,H180888 ,H181035 ,H181084 ,H181138 ,H182000 ,H270219 ,H270329 H270421 ,H270498 ,H270625, H270699 ,H180889 ,H181036 ,H181085 ,H181139 ,H182002 H270226 ,H270332 ,H270425 ,H270499 ,H270626 ,H270700 ,H180890 ,H181037 ,H181086 H181140 ,H182006 ,H270227 ,H270335 ,H270426 ,H270500 ,H270627 ,H270702 ,H180891 H181038 ,H181087 ,H181141 ,H182007 ,H270228 ,H270337 ,H270427 ,H270501 ,H270631 H270703 ,H180892 ,H181039 ,H181088 ,H181142 ,H182009 ,H270229 ,H270338 ,H270428 H270502 ,H270632 ,H270705 ,H180894 ,H181040 ,H181089 ,H181143 ,H182010 ,H270230 H270341 ,H270430 ,H270503 ,H270633 ,H270708 ,H180895 ,H181041 ,H181090 ,H181145 H182012 ,H270232 ,H270342 ,H270431 ,H270504 ,H270634 ,H270709 ,H180896 ,H181042 H181091 ,H181146 ,H270004 ,H270233 ,H270343 ,H270433 ,H270505 ,H270635 ,H270710 H180897 ,H181043 ,H181092 ,H181147 ,H270006 ,H270235 ,H270344 ,H270435 ,H270506 H270637 ,H270711 ,H180898 ,H181044 ,H181093 ,H181148 ,H270009 ,H270237 ,H270345 H270436 ,H270507 ,H270639 ,H270712 ,H180899 ,H181045 ,H181094 ,H181149 ,H270010 H270240 ,H270346 ,H270437 ,H270508 ,H270641 ,H270713 ,H180901 ,H181046 ,H181095 H181151 ,H270021 ,H270242 ,H270349 ,H270438 ,H270510 ,H270642 ,H270714 ,H180907 H181047 ,H181096 ,H181152 ,H270026 ,H270244 ,H270351 ,H270439 ,H270511 ,H270643 H270715 ,H181000 ,H181048 ,H181097 ,H181153 ,H270027 ,H270245 ,H270352 ,H270443 H270512 ,H270644 ,H270716 ,H181001 ,H181049 ,H181098 ,H181154 ,H270029 ,H270251 H270353 ,H270445 ,H270513 ,H270645 ,H270717 ,H181002 ,H181050 ,H181100 ,H181155 H270030 ,H270252 ,H270355 ,H270446 ,H270514 ,H270646 ,H270718 ,H181003 ,H181051 H181101 ,H181156 ,H270031 ,H270254 ,H270356 ,H270447 ,H270516 ,H270647 ,H270719 H181004 ,H181052 ,H181102 ,H181157 ,H270038 ,H270255 ,H270360 ,H270448 ,H270518 H270648 ,H270721 ,H181005 ,H181053 ,H181103 ,H181158 ,H270045 ,H270256 ,H270361 H270449 ,H270520 ,H270649 ,H270722 ,H181006 ,H181055 ,H181104 ,H181159 ,H270047 H270260 ,H270364 ,H270450 ,H270522 ,H270651 ,H270723 ,H181007 ,H181056 ,H181106 H181160 ,H270068 ,H270261 ,H270365 ,H270451 ,H270525 ,H270652 ,H270725 ,H181008 H181057 ,H181107 ,H181161 ,H270073 ,H270264 ,H270370 ,H270452 ,H270526 ,H270653 H270726 ,H181009 ,H181058 ,H181108 ,H181162 ,H270074 ,H270267 ,H270371 ,H270454 H270529 ,H270654 ,H270727 ,H181010 ,H181059 ,H181109 ,H181163 ,H270075 ,H270270 H270373 ,H270455 ,H270530 ,H270656 ,H270728 ,H181011 ,H181060 ,H181110 ,H181164 H270079 ,H270271 ,H270375 ,H270457 ,H270532 ,H270658 ,H270729 ,H181012 ,H181061 H181112 ,H181165 ,H270084 ,H270273 ,H270377 ,H270458 ,H270534 ,H270660 ,H270730 H181013 ,H181062 ,H181113 ,H181166 ,H270088 ,H270274 ,H270378 ,H270459 ,H270535 H270661 ,H270732 ,H181014 ,H181063 ,H181114 ,H181167 ,H270094 ,H270277 ,H270380 H270461 ,H270539 ,H270662 ,H270733 ,H181015 ,H181064 ,H181115 ,H181168 ,H270096 H270280 ,H270384 ,H270462 ,H270540 ,H270663 ,H270735 ,H181016 ,H181065 ,H181116 H181170 ,H270101 ,H270281 ,H270385 ,H270463 ,H270542 ,H270664 ,H270736 ,H181017 H181066 ,H181117 ,H181171 ,H270106 ,H270282 ,H270386 ,H270464 ,H270544 ,H270665 H270737 ,H181018 ,H181067 ,H181118 ,H181173 ,H270107 ,H270284 ,H270391 ,H270466 H270546 ,H270667 ,H270739 ,H181019 ,H181068 ,H181119 ,H181174 ,H270110 ,H270285 H270392 ,H270468 ,H270547 ,H270669 ,H270740 ,H181020 ,H181069 ,H181120 ,H181175 H270111 ,H270288 ,H270395 ,H270470 ,H270550 ,H270670 ,H270741 ,H181021 ,H181070 H181123 ,H181176 ,H270118 ,H270290 ,H270396 ,H270471 ,H270601 ,H270671 ,H270743 H181022 ,H181071 ,H181124 ,H181177 ,H270126 ,H270293 ,H270397 ,H270473 ,H270602 H270673 ,H270746 ,H181023 ,H181072 ,H181125 ,H181178 ,H270128 ,H270297 ,H270398 H270474 ,H270603 ,H270675 ,H270749 ,H181024 ,H181073 ,H181126 ,H181179 ,H270134 H270302 ,H270399 ,H270476 ,H270605 ,H270680 ,H270751 ,H181025 ,H181074 ,H181127 H181180 ,H270136 ,H270303 ,H270400 ,H270477 ,H270606 ,H270681 ,H270752 ,H181026 H181075 ,H181128 ,H181181 ,H270138 ,H270307 ,H270401 ,H270479 ,H270607 ,H270682 H270755 ,H181027 ,H181076 ,H181129 ,H181182 ,H270141 ,H270310 ,H270404 ,H270482 H270613 ,H270684 ,H270757 ,H181028 ,H181077 ,H181130 ,H181183 ,H270144 ,H270311 H270409 ,H270483 ,H270615 ,H270685 ,H270759 ,H181029 ,H181078 ,H181132 ,H181184 H270201 ,H270314 ,H270410 ,H270484 ,H270616 ,H270686 ,H270760 ,H181030 ,H181079 H181133 ,H181185 ,H270209 ,H270316 ,H270412 ,H270486 ,H270617 ,H270690 ,H270761 H181031 ,H181080 ,H181134 ,H181187 ,H270211 ,H270320 ,H270416 ,H270487 ,H270618 H270692 ,H270762 ,H181032 ,H181081 ,H181135 ,H181191 ,H270214 ,H270321 ,H270418 H270489 ,H270622 ,H270693 ,H270763 ,H181033 ,H181082 ,H181136 ,H181195 ,H270215 H270323 ,H270419 ,H270490 ,H270623 ,H270697 ,H270766 ,H270767 ,H270841 ,H270897 H271066 ,H271123 ,H271185 ,H271236 ,H271296 ,H271348 ,H271402 ,H271451 ,H270768 H270842 ,H270898 ,H271067 ,H271124 ,H271186 ,H271238 H271297 ,H271349 ,H271403 H271453 ,H270769 ,H270844 ,H270899 ,H271068 ,H271125 H271188 ,H271239 ,H271298 H271350 ,H271404 ,H271454 ,H270777 ,H270845 ,H271000 H271070 ,H271126 ,H271189 H271241 ,H271299 ,H271351 ,H271406 ,H271455 ,H270778 H270846 ,H271002 ,H271071 H271127 ,H271190 ,H271242 ,H271300 ,H271353 ,H271407 H271456 ,H270779 ,H270847 H271004 ,H271073 ,H271130 ,H271191 ,H271243 ,H271301 H271355 ,H271408 ,H271457 H270781 ,H270848 ,H271005 ,H271075 ,H271131 ,H271192 H271245 ,H271302 ,H271356 H271409 ,H271458 ,H270782 ,H270849 ,H271006 ,H271076 H271132 ,H271193 ,H271247 H271303 ,H271357 ,H271410 ,H271459 ,H270783 ,H270850 H271008 ,H271079 ,H271135 H271194 ,H271248 ,H271304 ,H271358 ,H271411 ,H271460 H270785 ,H270852 ,H271009 H271080 ,H271136 ,H271195 ,H271249 ,H271305 ,H271359 H271412 ,H271461 ,H270786 H270854 ,H271013 ,H271082 ,H271137 ,H271196 ,H271250 H271306 ,H271360 ,H271413 H271462 ,H270787 ,H270855 ,H271015 ,H271083 ,H271138 H271197 ,H271251 ,H271307 H271361 ,H271414 ,H271463 ,H270788 ,H270857 ,H271016 H271084 ,H271139 ,H271198 H271253 ,H271308 ,H271362 ,H271415 ,H271464 ,H270789 H270858 ,H271017 ,H271085 H271141 ,H271199 ,H271256 ,H271309 ,H271363 ,H271416 H271465 ,H270790 ,H270859 H271018 ,H271086 ,H271142 ,H271200 ,H271257 ,H271311 H271364 ,H271417 ,H271466 H270791 ,H270861 ,H271019 ,H271087 ,H271143 ,H271201 H271258 ,H271312 ,H271365 H271418 ,H271467 ,H270793 ,H270862 ,H271020 ,H271088 H271144 ,H271202 ,H271259 H271314 ,H271367 ,H271419 ,H271468 ,H270794 ,H270863 H271021 ,H271089 ,H271145 H271204 ,H271260 ,H271315 ,H271369 ,H271420 ,H271470 H270795 ,H270864 ,H271023 H271091 ,H271149 ,H271205 ,H271263 ,H271316 ,H271370 H271421 ,H271471 ,H270796 H270865 ,H271024 ,H271092 ,H271151 ,H271206 ,H271264 H271317 ,H271371 ,H271422 H271472 ,H270797 ,H270866 ,H271025 ,H271093 ,H271152 H271207 ,H271265 ,H271318 H271372 ,H271423 ,H271473 ,H270799 ,H270867 ,H271026 H271094 ,H271153 ,H271208 H271266 ,H271319 ,H271373 ,H271424 ,H271474 ,H270800 H270868 ,H271027 ,H271095 H271154 ,H271209 ,H271267 ,H271320 ,H271374 ,H271425 H271475 ,H270803 ,H270869 H271029 ,H271096 ,H271155 ,H271210 ,H271268 ,H271321 H271375 ,H271426 ,H271476 H270804 ,H270870 ,H271031 ,H271097 ,H271157 ,H271211 H271269 ,H271322 ,H271376 H271427 ,H271477 ,H270805 ,H270871 ,H271032 ,H271098 H271159 ,H271212 ,H271271 H271323 ,H271377 ,H271428 ,H271478 ,H270806 ,H270872 H271033 ,H271099 ,H271160 H271213 ,H271272 ,H271324 ,H271378 ,H271429 ,H271479 H270808 ,H270873 ,H271034 H271100 ,H271161 ,H271214 ,H271273 ,H271325 ,H271379 H271430 ,H271480 ,H270812 H270875 ,H271035 ,H271101 ,H271162 ,H271215 ,H271274 H271327 ,H271380 ,H271431 H271481 ,H270813 ,H270877 ,H271036 ,H271102 ,H271163 H271216 ,H271275 ,H271328 H271381 ,H271432 ,H271483 ,H270814 ,H270878 ,H271037 H271103 ,H271164 ,H271217 H271276 ,H271329 ,H271382 ,H271433 ,H271484 ,H270817 H270879 ,H271038 ,H271104 H271165 ,H271218 ,H271278 ,H271330 ,H271383 ,H271434 H271485 ,H270819 ,H270880 H271039 ,H271105 ,H271166 ,H271219 ,H271280 ,H271331 H271384 ,H271435 ,H271486 H270820 ,H270881 ,H271041 ,H271106 ,H271167 ,H271220 H271281 ,H271332 ,H271385 H271436 ,H271487 ,H270821 ,H270882 ,H271042 ,H271107 H271168 ,H271222 ,H271282 H271333 ,H271386 ,H271437 ,H271488 ,H270822 ,H270883 H271043 ,H271108 ,H271169 H271223 ,H271283 ,H271334 ,H271387 ,H271438 ,H271489 H270823 ,H270884 ,H271044 H271109 ,H271170 ,H271224 ,H271284 ,H271335 ,H271388 H271439 ,H271490 ,H270825 H270885 ,H271046 ,H271110 ,H271171 ,H271225 ,H271285 H271336 ,H271389 ,H271440 H271492 ,H270826 ,H270886 ,H271051 ,H271111 ,H271172 H271226 ,H271286 ,H271337 H271390 ,H271441 ,H271493 ,H270827 ,H270888 ,H271052 H271112 ,H271174 ,H271227 H271287 ,H271338 ,H271391 ,H271442 ,H271494 ,H270828 H270889 ,H271055 ,H271113 H271175 ,H271228 ,H271288 ,H271339 ,H271392 ,H271443 H271495 ,H270829 ,H270890 H271056 ,H271114 ,H271176 ,H271229 ,H271289 ,H271340 H271393 ,H271444 ,H271496 H270833 ,H270891 ,H271057 ,H271115 ,H271177 ,H271230 H271290 ,H271342 ,H271394 H271445 ,H271497 ,H270835 ,H270892 ,H271059 ,H271116 H271178 ,H271231 ,H271291 H271343 ,H271395 ,H271446 ,H271498 ,H270836 ,H270893 H271061 ,H271117 ,H271179 H271232 ,H271292 ,H271344 ,H271397 ,H271447 ,H271499 H270837 ,H270894 ,H271062 H271118 ,H271182 ,H271233 ,H271293 ,H271345 ,H271398 H271448 ,H271500 ,H270838 H270895 ,H271063 ,H271120 ,H271183 ,H271234 ,H271294 H271346 ,H271399 ,H271449 H271501 ,H270840 ,H270896 ,H271065 ,H271121 ,H271184 H271235 ,H271295 ,H271347 H271401 ,H271450 ,H271502 ,H271503 ,H271552 ,H271603 H271652 ,H271701 ,H271749 H271797 ,H271845 ,H271893 ,H271942 ,H271991 ,H271504 H271553 ,H271604 ,H271653 H271702 ,H271750 ,H271798 ,H271846 ,H271894 ,H271943 H271992 ,H271505 ,H271554 H271605 ,H271654 ,H271703 ,H271751 ,H271799 ,H271847 H271895 ,H271944 ,H271993 H271506 ,H271555 ,H271606 ,H271655 ,H271704 ,H271752 H271800 ,H271848 ,H271896 H271945 ,H271994 ,H271507 ,H271557 ,H271607 ,H271656 H271705 ,H271753 ,H271801 H271849 ,H271897 ,H271946 ,H271995 ,H271508 ,H271559 H271608 ,H271657 ,H271706 H271754 ,H271802 ,H271850 ,H271898 ,H271947 ,H271996 H271509 ,H271560 ,H271609 H271658 ,H271707 ,H271755 ,H271803 ,H271851 ,H271899 H271948 ,H271997 ,H271510 H271561 ,H271610 ,H271659 ,H271708 ,H271756 ,H271804 H271852 ,H271901 ,H271949 H271998 ,H271511 ,H271562 ,H271611 ,H271660 ,H271709 H271757 ,H271805 ,H271853 H271902 ,H271950 ,H271999 ,H271512 ,H271563 ,H271612 H271661 ,H271710 ,H271758 H271806 ,H271854 ,H271903 ,H271951 ,H272000 ,H271513 H271564 ,H271613 ,H271662 H271711 ,H271759 ,H271807 ,H271855 ,H271904 ,H271952 H272001 ,H271514 ,H271565 H271614 ,H271663 ,H271712 ,H271760 ,H271808 ,H271856 H271905 ,H271953 ,H272002 H271515 ,H271566 ,H271615 ,H271664 ,H271713 ,H271761 H271809 ,H271857 ,H271906 H271954 ,H272003 ,H271516 ,H271567 ,H271616 ,H271665 H271714 ,H271762 ,H271810 H271858 ,H271907 ,H271955 ,H272004 ,H271517 ,H271568 H271617 ,H271666 ,H271715 H271763 ,H271811 ,H271859 ,H271908 ,H271956 ,H272005 H271518 ,H271569 ,H271618 H271667 ,H271716 ,H271764 ,H271812 ,H271860 ,H271909 H271957 ,H272006 ,H271519 H271570 ,H271619 ,H271668 ,H271717 ,H271765 ,H271813 H271861 ,H271910 ,H271958 H272007 ,H271520 ,H271571 ,H271620 ,H271669 ,H271718 H271766 ,H271814 ,H271862 H271911 ,H271959 ,H272008 ,H271521 ,H271572 ,H271621 H271670 ,H271719 ,H271767 H271815 ,H271863 ,H271912 ,H271960 ,H272009 ,H271522 H271573 ,H271622 ,H271671 H271720 ,H271768 ,H271816 ,H271864 ,H271913 ,H271961 H272010 ,H271523 ,H271574 H271623 ,H271672 ,H271721 ,H271769 ,H271817 ,H271865 H271914 ,H271962 ,H272011 H271525 ,H271575 ,H271624 ,H271673 ,H271722 ,H271770 H271818 ,H271866 ,H271915 H271963 ,H272012 ,H271526 ,H271576 ,H271625 ,H271674 H271723 ,H271771 ,H271819 H271867 ,H271916 ,H271964 ,H272013 ,H271527 ,H271577 H271626 ,H271675 ,H271724 H271772 ,H271820 ,H271868 ,H271917 ,H271965 ,H272014 H271528 ,H271578 ,H271627 H271676 ,H271725 ,H271773 ,H271821 ,H271869 ,H271918 H271966 ,H272015 ,H271529 H271580 ,H271628 ,H271677 ,H271726 ,H271774 ,H271822 H271870 ,H271919 ,H271967 H272016 ,H271530 ,H271581 ,H271629 ,H271678 ,H271727 H271775 ,H271823 ,H271871 H271920 ,H271968 ,H272017 ,H271531 ,H271582 ,H271630 H271679 ,H271728 ,H271776 H271824 ,H271872 ,H271921 ,H271969 ,H272018 ,H271532 H271583 ,H271631 ,H271680 H271729 ,H271777 ,H271825 ,H271873 ,H271922 ,H271970 H272019 ,H271533 ,H271584 H271632 ,H271681 ,H271730 ,H271778 ,H271826 ,H271874 H271923 ,H271971 ,H272020 H271534 ,H271585 ,H271634 ,H271682 ,H271731 ,H271779 H271827 ,H271875 ,H271924 H271972 ,H272021 ,H271535 ,H271586 ,H271635 ,H271683 H271732 ,H271780 ,H271828 H271876 ,H271925 ,H271973 ,H272022 ,H271536 ,H271587 H271636 ,H271684 ,H271733 H271781 ,H271829 ,H271877 ,H271926 ,H271974 ,H272023 H271537 ,H271588 ,H271637 H271685 ,H271734 ,H271782 ,H271830 ,H271878 ,H271927 H271975 ,H272024 ,H271538 H271589 ,H271638 ,H271686 ,H271735 ,H271783 ,H271831 H271879 ,H271928 ,H271976 H272025 ,H271539 ,H271590 ,H271639 ,H271687 ,H271736 H271784 ,H271832 ,H271880 H271929 ,H271977 ,H272026 ,H271540 ,H271591 ,H271640 H271688 ,H271737 ,H271785 H271833 ,H271881 ,H271930 ,H271978 ,H272027 ,H271541 H271592 ,H271641 ,H271689 H271738 ,H271786 ,H271834 ,H271882 ,H271931 ,H271980 H272028 ,H271542 ,H271593 H271642 ,H271691 ,H271739 ,H271787 ,H271835 ,H271883 H271932 ,H271981 ,H272029 H271543 ,H271594 ,H271643 ,H271692 ,H271740 ,H271788 H271836 ,H271884 ,H271933 H271982 ,H272030 ,H271544 ,H271595 ,H271644 ,H271693 H271741 ,H271789 ,H271837 H271885 ,H271934 ,H271983 ,H272031 ,H271545 ,H271596 H271645 ,H271694 ,H271742 H271790 ,H271838 ,H271886 ,H271935 ,H271984 ,H272032 H271546 ,H271597 ,H271646 H271695 ,H271743 ,H271791 ,H271839 ,H271887 ,H271936 H271985 ,H272033 ,H271547 H271598 ,H271647 ,H271696 ,H271744 ,H271792 ,H271840 H271888 ,H271937 ,H271986 H272034 ,H271548 ,H271599 ,H271648 ,H271697 ,H271745 H271793 ,H271841 ,H271889 H271938 ,H271987 ,H272035 ,H271549 ,H271600 ,H271649 H271698 ,H271746 ,H271794 H271842 ,H271890 ,H271939 ,H271988 ,H272036 ,H271550 H271601 ,H271650 ,H271699 H271747 ,H271795 ,H271843 ,H271891 ,H271940 ,H271989 H272038 ,H271551 ,H271602 H271651 ,H271700 ,H271748 ,H271796 ,H271844 ,H271892 H271941 ,H271990 ,H272039 H272040 ,H272090 ,H272138 ,H272186 ,H272234 ,H272284 H272332 ,H272380 ,H272428 H272477 ,H272829 ,H272041 ,H272091 ,H272139 ,H272187 H272235 ,H272285 ,H272333 H272381 ,H272429 ,H272478 ,H272830 ,H272043 ,H272092 H272140 ,H272188 ,H272236 H272286 ,H272334 ,H272382 ,H272430 ,H272479 ,H272831 H272044 ,H272093 ,H272141 H272189 ,H272237 ,H272287 ,H272335 ,H272383 ,H272431 H272480 ,H272833 ,H272045 H272094 ,H272142 ,H272190 ,H272238 ,H272288 ,H272336 H272384 ,H272432 ,H272482 H272834 ,H272046 ,H272095 ,H272143 ,H272191 ,H272239 H272289 ,H272337 ,H272385 H272433 ,H272483 ,H272836 ,H272047 ,H272096 ,H272144 H272192 ,H272240 ,H272290 H272338 ,H272386 ,H272434 ,H272484 ,H272837 ,H272048 H272097 ,H272145 ,H272193 H272241 ,H272291 ,H272339 ,H272387 ,H272435 ,H272488 H272838 ,H272049 ,H272098 H272146 ,H272194 ,H272242 ,H272292 ,H272340 ,H272388 H272436 ,H272489 ,H272839 H272050 ,H272099 ,H272147 ,H272195 ,H272243 ,H272293 H272341 ,H272389 ,H272437 H272490 ,H272840 ,H272051 ,H272100 ,H272148 ,H272196 H272244 ,H272294 ,H272342 H272390 ,H272438 ,H272491 ,H272841 ,H272052 ,H272101 H272149 ,H272197 ,H272245 H272295 ,H272343 ,H272391 ,H272439 ,H272492 ,H272842 H272053 ,H272102 ,H272150 H272198 ,H272246 ,H272296 ,H272344 ,H272392 ,H272440 H272493 ,H272843 ,H272054 H272103 ,H272151 ,H272199 ,H272247 ,H272297 ,H272345 H272393 ,H272441 ,H272494 H272844 ,H272055 ,H272104 ,H272152 ,H272200 ,H272248 H272298 ,H272346 ,H272394 H272442 ,H272495 ,H272845 ,H272056 ,H272105 ,H272153 H272201 ,H272249 ,H272299 H272347 ,H272395 ,H272443 ,H272496 ,H272846 ,H272057 H272106 ,H272154 ,H272202 H272250 ,H272300 ,H272348 ,H272396 ,H272444 ,H272497 H272847 ,H272058 ,H272107 H272155 ,H272203 ,H272251 ,H272301 ,H272349 ,H272397 H272445 ,H272498 ,H272848 H272059 ,H272108 ,H272156 ,H272204 ,H272253 ,H272302 H272350 ,H272398 ,H272446 H272500 ,H272849 ,H272060 ,H272109 ,H272157 ,H272205 H272254 ,H272303 ,H272351 H272399 ,H272447 ,H272800 ,H272850 ,H272061 ,H272110 H272158 ,H272206 ,H272255 H272304 ,H272352 ,H272400 ,H272448 ,H272801 ,H272851 H272062 ,H272111 ,H272159 ,H272207 ,H272256 ,H272305 ,H272353 ,H272401 ,H272449 H272802 ,H272852 ,H272064 ,H272112 ,H272160 ,H272208 ,H272258 ,H272306 ,H272354 H272402 ,H272450 ,H272803 ,H272853 ,H272065 ,H272113 ,H272161 ,H272209 ,H272259 H272307 ,H272355 ,H272403 ,H272451 ,H272804 ,H272854 ,H272066 ,H272114 ,H272162 H272210 ,H272260 ,H272308 ,H272356 ,H272404 ,H272452 ,H272805 ,H272855 ,H272067 H272115 ,H272163 ,H272211 H272261 ,H272309 ,H272357 ,H272405 ,H272453 ,H272806 H272856 ,H272068 ,H272116 H272164 ,H272212 ,H272262 ,H272310 ,H272358 ,H272406 H272454 ,H272807 ,H272857 H272069 ,H272117 ,H272165 ,H272213 ,H272263 ,H272311 H272359 ,H272407 ,H272455 H272808 ,H272858 ,H272070 ,H272118 ,H272166 ,H272214 H272264 ,H272312 ,H272360 ,H272408 ,H272456 ,H272809 ,H272859 ,H272071 ,H272119 H272167 ,H272215 ,H272265 ,H272313 ,H272361 ,H272409 ,H272457 ,H272810 H272860 H272072 ,H272120 ,H272168 ,H272216 ,H272266 ,H272314 ,H272362 ,H272410 H272458 H272811 ,H272861 ,H272073 ,H272121 H272169 ,H272217 H272267 ,H272315 ,H272363 H272411 ,H272459 ,H272812 ,H272862 ,H272074 H272122 H272170 ,H272218, H272268, H272316 ,H272364 ,H272412 ,H272460 H272813 H272863 H272075 ,H272123 ,H272171 H272219 ,H272269 ,H272317, ,H272365 ,H272413 ,H272461 ,H272814 ,H272864 H272076 H272124 ,H272172 ,H272220 ,H272270 ,H272318 ,H272366 ,H272414 ,H272462 H272815 H272865 ,H272077 ,H272125 ,H272173 ,H272221 ,H272271 ,H272319 ,H272367 H272415 H272463 ,H272816 ,H272866 ,H272078 ,H272126 ,H272174 ,H272222 ,H272272 H272320 H272368 ,H272416 ,H272464 ,H272817 ,H272867 ,H272079 ,H272127 ,H272175 ,H272223 H272273 ,H272321 ,H272369 ,H272417 ,H272465 ,H272818 ,H272868 ,H272080 ,H272128 H272176 ,H272224 ,H272274 ,H272322 ,H272370 ,H272418 ,H272466 ,H272819 ,H272869 H272081 ,H272129 ,H272177 ,H272225 ,H272275 ,H272323 ,H272371 ,H272419 ,H272467 H272820 ,H272870 ,H272082 ,H272130 ,H272178 ,H272226 ,H272276 ,H272324 ,H272372 H272420 ,H272468 ,H272821 ,H272871 ,H272083 ,H272131 ,H272179 ,H272227 ,H272277 H272325 ,H272373 ,H272421 ,H272469 ,H272822 ,H272872 ,H272084 ,H272132 ,H272180 H272228 ,H272278 ,H272326 ,H272374 ,H272422 ,H272470 ,H272823 ,H272873 ,H272085 H272133 ,H272181 ,H272229 ,H272279 ,H272327 ,H272375 ,H272423 ,H272471 ,H272824 H272875 ,H272086 ,H272134 ,H272182 ,H272230 ,H272280 ,H272328 ,H272376 ,H272424 H272472 ,H272825 ,H272876 ,H272087 ,H272135 ,H272183 ,H272231 ,H272281 ,H272329 H272377 ,H272425 ,H272473 ,H272826 ,H272877 ,H272088 ,H272136 ,H272184 ,H272232 H272282 ,H272330 ,H272378 ,H272426 ,H272475 ,H272827 ,H272878 ,H272089 ,H272137 H272185 ,H272233 ,H272283 ,H272331 ,H272379 ,H272427 ,H272476 ,H272828 ,H272879 H272880 ,H272928 ,H272977 ,H273028 ,H273079 ,H273128 ,H273183 ,H290119 ,H290194 H290244 ,H290297 ,H272881 ,H272929 ,H272978 ,H273029 ,H273080 ,H273130 ,H273184 H290121 ,H290195 ,H290246 ,H290299 ,H272882 ,H272930 ,H272979 ,H273030 ,H273081 H273131 ,H273185 ,H290122 ,H290196 ,H290247 ,H290301 ,H272883 ,H272931 ,H272980 H273031 ,H273082 ,H273132 ,H273186 ,H290123 ,H290197 ,H290248 ,H290302 ,H272884 H272932 ,H272981 ,H273032 ,H273083 ,H273133 ,H273187 ,H290125 ,H290198 ,H290249 H290304 ,H272885 ,H272933 ,H272982 ,H273033 ,H273084 ,H273134 ,H273189 ,H290128 H290199 ,H290250 ,H290305 ,H272886 ,H272934 ,H272983 ,H273034 ,H273085 ,H273135 H273190 ,H290130 ,H290200 ,H290253 ,H290306 ,H272887 ,H272935 ,H272984 ,H273035 H273086 ,H273136 ,H273191 ,H290132 ,H290201 ,H290254 ,H290307 ,H272888 ,H272936 H272985 ,H273036 ,H273087 ,H273137 ,H273193 ,H290135 ,H290202 ,H290255 ,H290308 H272889 ,H272937 ,H272986 ,H273037 ,H273088 ,H273138 ,H273194 ,H290137 ,H290203 H290256 ,H290309 ,H272890 ,H272938 ,H272988 ,H273038 ,H273089 ,H273140 ,H273195 H290138 ,H290204 ,H290257 ,H290310 ,H272891 ,H272939 ,H272989 ,H273039 ,H273090 H273141 ,H273196 ,H290139 ,H290205 ,H290258 ,H290311 ,H272892 ,H272940 ,H272990 H273040 ,H273091 ,H273142 ,H273197 ,H290141 ,H290206 ,H290259 ,H290312 ,H272893 H272941 ,H272991 ,H273041 ,H273092 ,H273143 ,H273198 ,H290142 ,H290208 ,H290260 H290313 ,H272894 ,H272942 ,H272992 ,H273042 ,H273093 ,H273144 ,H273199 ,H290143 H290209 ,H290261 ,H290314 ,H272895 ,H272943 ,H272993 ,H273043 ,H273094 ,H273145 H273200 ,H290144 ,H290210 ,H290262 ,H290315 ,H272896 ,H272944 ,H272994 ,H273044 H273095 ,H273147 ,H273201 ,H290145 ,H290211 ,H290263 ,H290316 ,H272897 ,H272946 H272995 ,H273045 ,H273097 ,H273148 ,H273202 ,H290146 ,H290212 ,H290264 ,H290317 H272898 ,H272947 ,H272996 ,H273046 ,H273098 ,H273149 ,H273203 ,H290151 ,H290213 H290265 ,H290318 ,H272899 ,H272948 ,H272997 ,H273047 ,H273099 ,H273150 ,H273204 H290152 ,H290214 ,H290266 ,H290319 ,H272900 ,H272949 ,H272998 ,H273048 ,H273100 H273151 ,H273206 ,H290154 ,H290215 ,H290267 ,H290320 ,H272901 ,H272950 ,H272999 H273049 ,H273101 ,H273152 ,H273208 ,H290155 ,H290216 ,H290268 ,H290321 ,H272902 H272951 ,H273000 ,H273050 ,H273102 ,H273153 ,H273209 ,H290156 ,H290217 ,H290269 H290322 ,H272903 ,H272952 ,H273001 ,H273051 ,H273103 ,H273155 ,H273210 ,H290157 H290218 ,H290271 ,H290323 ,H272904 ,H272953 ,H273002 ,H273052 ,H273104 ,H273156 H290001 ,H290158 ,H290219 ,H290272 ,H290324 ,H272905 ,H272954 ,H273003 ,H273053 H273105 ,H273157 ,H290003 ,H290159 ,H290220 ,H290273 ,H290325 ,H272906 ,H272955 H273004 ,H273054 ,H273106 ,H273158 ,H290012 ,H290160 ,H290221 ,H290274 ,H290326 H272907 ,H272956 ,H273005 ,H273055 ,H273107 ,H273159 ,H290017 ,H290161 ,H290222 H290275 ,H290327 ,H272908 ,H272957 ,H273006 ,H273056 ,H273108 ,H273160 ,H290021 H290162 ,H290223 ,H290276 ,H290328 ,H272909 ,H272958 ,H273007 ,H273057 ,H273109 H273162 ,H290026 ,H290164 ,H290224 ,H290277 ,H290329 ,H272910 ,H272959 ,H273008 H273058 ,H273110 ,H273163 ,H290027 ,H290165 ,H290225 ,H290278 ,H290330 ,H272911 H272960 ,H273010 ,H273059 ,H273111 ,H273164 ,H290030 ,H290166 ,H290226 ,H290279 H290331 ,H272912 ,H272961 ,H273011 ,H273060 ,H273112 ,H273165 ,H290031 ,H290168 H290227 ,H290280 ,H290332 ,H272913 ,H272962 ,H273012 ,H273061 ,H273113 ,H273166 H290032 ,H290171 ,H290228 ,H290281 ,H290333 ,H272914 ,H272963 ,H273013 ,H273062 H273114 ,H273167 ,H290033 ,H290173 ,H290229 ,H290282 ,H290334 ,H272915 ,H272964 H273014 ,H273063 ,H273115 ,H273170 ,H290034 ,H290175 ,H290230 ,H290283 ,H290335 H272916 ,H272965 ,H273016 ,H273065 ,H273116 ,H273171 ,H290100 ,H290176 ,H290231 H290284 ,H290336 ,H272917 ,H272966 ,H273017 ,H273066 ,H273117 ,H273172 ,H290103 H290180 ,H290232 ,H290285 ,H290337 ,H272918 ,H272967 ,H273018 ,H273067 ,H273118 H273173 ,H290104 ,H290181 ,H290233 ,H290286 ,H290338 ,H272919 ,H272968 ,H273019 H273068 ,H273119 ,H273174 ,H290105 ,H290182 ,H290234 ,H290287 ,H290339 ,H272920 H272969 ,H273020 ,H273069 ,H273120 ,H273175 ,H290108 ,H290183 ,H290235 ,H290288 H290340 ,H272921 ,H272970 ,H273021 ,H273070 ,H273121 ,H273176 ,H290109 ,H290185 H290236 ,H290289 ,H290341 ,H272922 ,H272971 ,H273022 ,H273071 ,H273122 ,H273177 H290110 ,H290186 ,H290237 ,H290290 ,H290342 ,H272923 ,H272972 ,H273023 ,H273072 H273123 ,H273178 ,H290111 ,H290187 ,H290239 ,H290291 ,H290343 ,H272924 ,H272973 H273024 ,H273074 ,H273124 ,H273179 ,H290113 ,H290189 ,H290240 ,H290292 ,H290344 H272925 ,H272974 ,H273025 ,H273075 ,H273125 ,H273180 ,H290114 ,H290191 ,H290241 H290293 ,H290345 ,H272926 ,H272975 ,H273026 ,H273077 ,H273126 ,H273181 ,H290116 H290192 ,H290242 ,H290295 ,H290346 ,H272927 ,H272976 ,H273027 ,H273078 ,H273127 H273182 ,H290118 ,H290193 ,H290243 ,H290296 ,H290347 ,H290348 ,H290398 ,H290523 H291009 ,H291059 ,H291108 ,H291157 ,H291205 ,H291253 ,H293324 ,H293372 ,H290349 H290399 ,H290524 ,H291010 ,H291060 ,H291109 ,H291158 ,H291206 ,H291254 ,H293325 H293373 ,H290350 ,H290400 ,H290525 ,H291011 ,H291061 ,H291111 ,H291159 ,H291207 H291255 ,H293326 ,H293374 ,H290351 ,H290401 ,H290526 ,H291012 ,H291062 ,H291112 H291160 ,H291208 ,H291256 ,H293327 ,H293375 ,H290352 ,H290402 ,H290527 ,H291013 H291063 ,H291113 ,H291161 ,H291209 ,H291257 ,H293328 ,H293376 ,H290353 ,H290403 H290528 ,H291014 ,H291064 ,H291114 ,H291162 ,H291210 ,H291258 ,H293329 ,H293377 H290354 ,H290404 ,H290529 ,H291015 ,H291065 ,H291115 ,H291163 ,H291211 ,H291259 H293330 ,H293378 ,H290355 ,H290405 ,H290530 ,H291016 ,H291066 ,H291116 ,H291164 H291212 ,H291260 ,H293331 ,H293379 ,H290356 ,H290406 ,H290531 ,H291017 ,H291067 H291117 ,H291165 ,H291213 ,H291261 ,H293332 ,H293380 ,H290357 ,H290408 ,H290532 H291018 ,H291068 ,H291118 ,H291166 ,H291214 ,H291262 ,H293333 ,H293381 ,H290358 H290409 ,H290533 ,H291019 ,H291069 ,H291119 ,H291167 ,H291215 ,H291263 ,H293334 H293382 ,H290359 ,H290410 ,H290534 ,H291020 ,H291070 ,H291120 ,H291168 ,H291216 H291264 ,H293335 ,H293383 ,H290360 ,H290411 ,H290535 ,H291021 ,H291071 ,H291121 H291169 ,H291217 ,H291265 ,H293336 ,H293384 ,H290362 ,H290412 ,H290536 ,H291022 H291072 ,H291122 ,H291170 ,H291218 ,H291266 ,H293337 ,H293385 ,H290363 ,H290413 H290537 ,H291023 ,H291073 ,H291123 ,H291171 ,H291219 ,H291267 ,H293338 ,H293386 H290364 ,H290414 ,H290538 ,H291024 ,H291074 ,H291124 ,H291172 ,H291220 ,H291268 H293339 ,H293387 ,H290365 ,H290415 ,H290539 ,H291025 ,H291075 ,H291125 ,H291173 H291221 ,H291269 ,H293340 ,H293388 ,H290366 ,H290416 ,H290540 ,H291026 ,H291076 H291126 ,H291174 ,H291222 ,H291270 ,H293341 ,H293389 ,H290367 ,H290417 ,H290541 H291027 ,H291077 ,H291127 ,H291175 ,H291223 ,H291271 ,H293342 ,H293390 ,H290368 H290422 ,H290542 ,H291028 ,H291078 ,H291128 ,H291176 ,H291224 ,H291272 ,H293343 H293391 ,H290369 ,H290423 ,H290543 ,H291029 ,H291079 ,H291129 ,H291177 ,H291225 H291273 ,H293344 ,H293393 ,H290370 ,H290424 ,H290544 ,H291030 ,H291080 ,H291130 H291178 ,H291226 ,H292832 ,H293345 ,H293394 ,H290371 ,H290425 ,H290545 ,H291031 H291081 ,H291131 ,H291179 ,H291227 ,H293009 ,H293346 ,H293395 ,H290372 ,H290426 H290546 ,H291032 ,H291082 ,H291132 ,H291180 ,H291228 ,H293207 ,H293347 ,H293396 H290373 ,H290427 ,H290547 ,H291034 ,H291083 ,H291133 ,H291181 ,H291229 ,H293300 H293348 ,H293397 ,H290374 ,H290500 ,H290548 ,H291035 ,H291084 ,H291134 ,H291182 H291230 ,H293301 ,H293349 ,H293398 ,H290375 ,H290501 ,H290549 ,H291036 ,H291085 H291135 ,H291183 ,H291231 ,H293302 ,H293350 ,H293399 ,H290376 ,H290502 ,H290550 H291037 ,H291086 ,H291136 ,H291184 ,H291232 ,H293303 ,H293351 ,H293401 ,H290377 H290503 ,H290551 ,H291038 ,H291087 ,H291137 ,H291185 ,H291233 ,H293304 ,H293352 H293402 ,H290378 ,H290504 ,H290552 ,H291039 ,H291088 ,H291138 ,H291186 ,H291234 H293305 ,H293353 ,H293403 ,H290379 ,H290505 ,H290553 ,H291040 ,H291089 ,H291139 H291187 ,H291235 ,H293306 ,H293354 ,H293404 ,H290380 ,H290506 ,H290554 ,H291041 H291090 ,H291140 ,H291188 ,H291236 ,H293307 ,H293355 ,H293405 ,H290381 ,H290507 H290555 ,H291042 ,H291091 ,H291141 ,H291189 ,H291237 ,H293308 ,H293356 ,H293406 H290382 ,H290508 ,H290556 ,H291043 ,H291092 ,H291142 ,H291190 ,H291238 ,H293309 H293357 ,H293407 ,H290383 ,H290509 ,H290557 ,H291044 ,H291093 ,H291143 ,H291191 H291239 ,H293310 ,H293358 ,H293408 ,H290384 ,H290510 ,H290558 ,H291045 ,H291094 H291144 ,H291192 ,H291240 ,H293311 ,H293359 ,H293409 ,H290385 ,H290511 ,H290559 H291046 ,H291095 ,H291145 ,H291193 ,H291241 ,H293312 ,H293360 ,H293410 ,H290386 H290512 ,H290560 ,H291047 ,H291096 ,H291146 ,H291194 ,H291242 ,H293313 ,H293361 H293411 ,H290387 ,H290513 ,H290561 ,H291048 ,H291097 ,H291147 ,H291195 ,H291243 H293314 ,H293362 ,H293412 ,H290388 ,H290514 ,H290600 ,H291049 ,H291098 ,H291148 H291196 ,H291244 ,H293315 ,H293363 ,H293413 ,H290389 ,H290515 ,H291001 ,H291050 H291099 ,H291149 ,H291197 ,H291245 ,H293316 ,H293364 ,H293414 ,H290390 ,H290516 H291002 ,H291051 ,H291101 ,H291150 ,H291198 ,H291246 ,H293317 ,H293365 ,H293415 H290392 ,H290517 ,H291003 ,H291052 ,H291102 ,H291151 ,H291199 ,H291247 ,H293318 H293366 ,H293416 ,H290393 ,H290518 ,H291004 ,H291053 ,H291103 ,H291152 ,H291200 H291248 ,H293319 ,H293367 ,H293417 ,H290394 ,H290519 ,H291005 ,H291054 ,H291104 H291153 ,H291201 ,H291249 ,H293320 ,H293368 ,H293418 ,H290395 ,H290520 ,H291006 H291055 ,H291105 ,H291154 ,H291202 ,H291250 ,H293321 ,H293369 ,H293419 ,H290396 H290521 ,H291007 ,H291056 ,H291106 ,H291155 ,H291203 ,H291251 ,H293322 ,H293370 H293420 ,H290397 ,H290522 ,H291008 ,H291057 ,H291107 ,H291156 ,H291204 ,H291252 H293323 ,H293371 ,H293421 ,H293422 ,H293470 ,H293518 ,H293568 ,H293618 ,H293666 H293716 ,H293766 ,H293814 ,H293863 ,H293911 ,H293423 ,H293471 ,H293519 ,H293569 H293619 ,H293667 ,H293717 ,H293767 ,H293815 ,H293864 ,H293912 ,H293424 ,H293472 H293520 ,H293570 ,H293620 ,H293668 ,H293718 ,H293768 ,H293816 ,H293865 ,H293913 H293425 ,H293473 ,H293521 ,H293571 ,H293621 ,H293669 ,H293719 ,H293769 ,H293817 H293866 ,H293914 ,H293426 ,H293474 ,H293522 ,H293572 ,H293622 ,H293670 ,H293720 H293770 ,H293818 ,H293867 ,H293915 ,H293427 ,H293475 ,H293523 ,H293573 ,H293623 H293671 ,H293721 ,H293771 ,H293819 ,H293868 ,H293916 ,H293428 ,H293476 ,H293524 H293574 ,H293624 ,H293672 ,H293723 ,H293772 ,H293820 ,H293869 ,H293917 ,H293429 H293477 ,H293525 ,H293575 ,H293625 ,H293673 ,H293724 ,H293773 ,H293821 ,H293870 H293918 ,H293430 ,H293478 ,H293527 ,H293576 ,H293626 ,H293674 ,H293725 ,H293774 H293822 ,H293871 ,H293919 ,H293431 ,H293479 ,H293528 ,H293577 ,H293627 ,H293675 H293726 ,H293775 ,H293823 ,H293872 ,H293920 ,H293432 ,H293480 ,H293529 ,H293578 H293628 ,H293676 ,H293727 ,H293776 ,H293824 ,H293873 ,H293921 ,H293433 ,H293481 H293530 ,H293579 ,H293629 ,H293677 ,H293728 ,H293777 ,H293825 ,H293874 ,H293922 H293434 ,H293482 ,H293531 ,H293581 ,H293630 ,H293678 ,H293729 ,H293778 ,H293826 H293875 ,H293923 ,H293435 ,H293483 ,H293532 ,H293583 ,H293631 ,H293679 ,H293730 H293779 ,H293827 ,H293876 ,H293924 ,H293436 ,H293484 ,H293533 ,H293584 ,H293632 H293681 ,H293731 ,H293780 ,H293828 ,H293877 ,H293925 ,H293437 ,H293485 ,H293534 H293585 ,H293633 ,H293682 ,H293732 ,H293781 ,H293829 ,H293878 ,H293926 ,H293438 H293486 ,H293535 ,H293586 ,H293634 ,H293683 ,H293733 ,H293782 ,H293830 ,H293879 H293928 ,H293439 ,H293487 ,H293536 ,H293587 ,H293635 ,H293684 ,H293734 ,H293783 H293831 ,H293880 ,H293929 ,H293440 ,H293488 ,H293537 ,H293588 ,H293636 ,H293685 H293735 ,H293784 ,H293832 ,H293881 ,H293930 ,H293441 ,H293489 ,H293538 ,H293589 H293637 ,H293686 ,H293736 ,H293785 ,H293833 ,H293882 ,H293931 ,H293442 ,H293490 H293539 ,H293590 ,H293638 ,H293687 ,H293737 ,H293786 ,H293834 ,H293883 ,H293932 H293443 ,H293491 ,H293540 ,H293591 ,H293639 ,H293688 ,H293738 ,H293787 ,H293835 H293884 ,H293933 ,H293444 ,H293492 ,H293541 ,H293592 ,H293640 ,H293689 ,H293739 H293788 ,H293836 ,H293885 ,H293934 ,H293445 ,H293493 ,H293542 ,H293593 ,H293641 H293690 ,H293740 ,H293789 ,H293837 ,H293886 ,H293935 ,H293446 ,H293494 ,H293543 H293594 ,H293642 ,H293691 ,H293741 ,H293790 ,H293838 ,H293887 ,H293936 ,H293447 H293495 ,H293544 ,H293595 ,H293643 ,H293692 ,H293742 ,H293791 ,H293839 ,H293888 H293938 ,H293448 ,H293496 ,H293545 ,H293596 ,H293644 ,H293693 ,H293743 ,H293792 H293840 ,H293889 ,H293940 ,H293449 ,H293497 ,H293546 ,H293597 ,H293645 ,H293694 H293744 ,H293793 ,H293841 ,H293890 ,H293941 ,H293450 ,H293498 ,H293548 ,H293598 H293646 ,H293695 ,H293745 ,H293794 ,H293842 ,H293891 ,H293942 ,H293451 ,H293499 H293549 ,H293599 ,H293647 ,H293696 ,H293746 ,H293795 ,H293843 ,H293892 ,H293943 H293452 ,H293500 ,H293550 ,H293600 ,H293648 ,H293697 ,H293747 ,H293796 ,H293844 H293893 ,H293944 ,H293453 ,H293501 ,H293551 ,H293601 ,H293649 ,H293698 ,H293748 H293797 ,H293845 ,H293894 ,H293946 ,H293454 ,H293502 ,H293552 ,H293602 ,H293650 H293699 ,H293749 ,H293798 ,H293846 ,H293895 ,H293947 ,H293455 ,H293503 ,H293553 H293603 ,H293651 ,H293700 ,H293750 ,H293799 ,H293847 ,H293896 ,H293948 ,H293456 H293504 ,H293554 ,H293604 ,H293652 ,H293701 ,H293751 ,H293800 ,H293848 ,H293897 H293949 ,H293457 ,H293505 ,H293555 ,H293605 ,H293653 ,H293702 ,H293752 ,H293801 H293849 ,H293898 ,H293950 ,H293458 ,H293506 ,H293556 ,H293606 ,H293654 ,H293703 H293753 ,H293802 ,H293850 ,H293899 ,H293951 ,H293459 ,H293507 ,H293557 ,H293607 H293655 ,H293704 ,H293754 ,H293803 ,H293851 ,H293900 ,H293952 ,H293460 ,H293508 H293558 ,H293608 ,H293656 ,H293705 ,H293755 ,H293804 ,H293852 ,H293901 ,H293953 H293461 ,H293509 ,H293559 ,H293609 ,H293657 ,H293706 ,H293756 ,H293805 ,H293854 H293902 ,H293954 ,H293462 ,H293510 ,H293560 ,H293610 ,H293658 ,H293707 ,H293758 H293806 ,H293855 ,H293903 ,H293955 ,H293463 ,H293511 ,H293561 ,H293611 ,H293659 H293708 ,H293759 ,H293807 ,H293856 ,H293904 ,H293956 ,H293464 ,H293512 ,H293562 H293612 ,H293660 ,H293709 ,H293760 ,H293808 ,H293857 ,H293905 ,H293957 ,H293465 H293513 ,H293563 ,H293613 ,H293661 ,H293710 ,H293761 ,H293809 ,H293858 ,H293906 H293958 ,H293466 ,H293514 ,H293564 ,H293614 ,H293662 ,H293712 ,H293762 ,H293810 H293859 ,H293907 ,H293959 ,H293467 ,H293515 ,H293565 ,H293615 ,H293663 ,H293713 H293763 ,H293811 ,H293860 ,H293908 ,H293960 ,H293468 ,H293516 ,H293566 ,H293616 H293664 ,H293714 ,H293764 ,H293812 ,H293861 ,H293909 ,H293961 ,H293469 ,H293517 H293567 ,H293617 ,H293665 ,H293715 ,H293765 ,H293813 ,H293862 ,H293910 ,H293962 H293963 ,H294012 ,H294061 ,H294110 ,H294161 ,H294209 ,H294260 ,H294309 ,H294357 H294406 ,H294458 ,H293964 ,H294013 ,H294062 ,H294111 ,H294162 ,H294210 ,H294261 H294310 ,H294358 ,H294407 ,H294460 ,H293965 ,H294014 ,H294063 ,H294112 ,H294163 H294211 ,H294262 ,H294311 ,H294359 ,H294408 ,H294461 ,H293966 ,H294015 ,H294064 H294113 ,H294164 ,H294212 ,H294263 ,H294312 ,H294360 ,H294409 ,H294462 ,H293967 H294016 ,H294065 ,H294114 ,H294165 ,H294213 ,H294264 ,H294313 ,H294361 ,H294410 H294463 ,H293968 ,H294017 ,H294066 ,H294116 ,H294166 ,H294214 ,H294265 ,H294314 H294362 ,H294411 ,H294464 ,H293969 ,H294018 ,H294067 ,H294117 ,H294167 ,H294215 H294266 ,H294315 ,H294363 ,H294412 ,H294465 ,H293970 ,H294020 ,H294068 ,H294118 H294168 ,H294216 ,H294267 ,H294316 ,H294364 ,H294413 ,H294466 ,H293971 ,H294021 H294069 ,H294119 ,H294169 ,H294217 ,H294268 ,H294317 ,H294365 ,H294414 ,H294467 H293972 ,H294022 ,H294070 ,H294120 ,H294170 ,H294218 ,H294269 ,H294318 ,H294366 H294415 ,H294468 ,H293974 ,H294023 ,H294071 ,H294121 ,H294171 ,H294219 ,H294270 H294319 ,H294367 ,H294416 ,H294469 ,H293975 ,H294024 ,H294072 ,H294122 ,H294172 H294220 ,H294271 ,H294320 ,H294368 ,H294417 ,H294470 ,H293976 ,H294025 ,H294073 H294123 ,H294173 ,H294221 ,H294272 ,H294321 ,H294369 ,H294418 ,H294471 ,H293977 H294026 ,H294074 ,H294124 ,H294174 ,H294222 ,H294273 ,H294322 ,H294370 ,H294419 H294472 ,H293978 ,H294027 ,H294075 ,H294125 ,H294175 ,H294223 ,H294274 ,H294323 H294371 ,H294420 ,H294473 ,H293979 ,H294028 ,H294076 ,H294126 ,H294176 ,H294224 H294275 ,H294324 ,H294372 ,H294421 ,H294474 ,H293980 ,H294029 ,H294077 ,H294127 H294177 ,H294225 ,H294276 ,H294325 ,H294373 ,H294422 ,H294475 ,H293981 ,H294030 H294078 ,H294128 ,H294178 ,H294226 ,H294277 ,H294326 ,H294374 ,H294423 ,H294476 H293982 ,H294031 ,H294079 ,H294129 ,H294179 ,H294227 ,H294278 ,H294327 ,H294376 H294424 ,H294477 ,H293983 ,H294032 ,H294080 ,H294130 ,H294180 ,H294228 ,H294279 H294328 ,H294377 ,H294425 ,H294478 ,H293984 ,H294033 ,H294081 ,H294131 ,H294181 H294229 ,H294280 ,H294329 ,H294378 ,H294426 ,H294479 ,H293985 ,H294034 ,H294082 H294132 ,H294182 ,H294230 ,H294281 ,H294330 ,H294379 ,H294427 ,H294480 ,H293986 H294035 ,H294083 ,H294133 ,H294183 ,H294231 ,H294283 ,H294331 ,H294380 ,H294428 H294481 ,H293987 ,H294036 ,H294084 ,H294134 ,H294184 ,H294232 ,H294284 ,H294332 H294381 ,H294429 ,H294482 ,H293988 ,H294037 ,H294085 ,H294135 ,H294185 ,H294233 H294285 ,H294333 ,H294382 ,H294430 ,H294483 ,H293989 ,H294038 ,H294086 ,H294136 H294186 ,H294234 ,H294286 ,H294334 ,H294383 ,H294431 ,H294484 ,H293990 ,H294039 H294087 ,H294137 ,H294187 ,H294235 ,H294287 ,H294335 ,H294384 ,H294432 ,H294485 H293991 ,H294040 ,H294088 ,H294140 ,H294188 ,H294236 ,H294288 ,H294336 ,H294385 H294433 ,H294486 ,H293992 ,H294041 ,H294089 ,H294141 ,H294189 ,H294237 ,H294289 H294337 ,H294386 ,H294434 ,H294487 ,H293993 ,H294042 ,H294090 ,H294142 ,H294190 H294238 ,H294290 ,H294338 ,H294387 ,H294435 ,H294488 ,H293994 ,H294043 ,H294091 H294143 ,H294191 ,H294239 ,H294291 ,H294339 ,H294388 ,H294436 ,H294489 ,H293995 H294044 ,H294092 ,H294144 ,H294192 ,H294240 ,H294292 ,H294340 ,H294389 ,H294437 H294490 ,H293996 ,H294045 ,H294093 ,H294145 ,H294193 ,H294241 ,H294293 ,H294341 H294390 ,H294438 ,H294491 ,H293997 ,H294046 ,H294094 ,H294146 ,H294194 ,H294242 H294294 ,H294342 ,H294391 ,H294439 ,H294492 ,H293998 ,H294047 ,H294095 ,H294147 H294195 ,H294243 ,H294295 ,H294343 ,H294392 ,H294440 ,H294493 ,H293999 ,H294048 H294097 ,H294148 ,H294196 ,H294244 ,H294296 ,H294344 ,H294393 ,H294441 ,H294494 H294000 ,H294049 ,H294098 ,H294149 ,H294197 ,H294245 ,H294297 ,H294345 ,H294394 H294442 ,H294495 ,H294001 ,H294050 ,H294099 ,H294150 ,H294198 ,H294246 ,H294298 H294346 ,H294395 ,H294443 ,H294496 ,H294002 ,H294051 ,H294100 ,H294151 ,H294199 H294247 ,H294299 ,H294347 ,H294396 ,H294444 ,H294497 ,H294003 ,H294052 ,H294101 H294152 ,H294200 ,H294248 ,H294300 ,H294348 ,H294397 ,H294445 ,H294498 ,H294004 H294053 ,H294102 ,H294153 ,H294201 ,H294250 ,H294301 ,H294349 ,H294398 ,H294446 H294499 ,H294005 ,H294054 ,H294103 ,H294154 ,H294202 ,H294252 ,H294302 ,H294350 H294399 ,H294447 ,H294500 ,H294006 ,H294055 ,H294104 ,H294155 ,H294203 ,H294253 H294303 ,H294351 ,H294400 ,H294448 ,H294501 ,H294007 ,H294056 ,H294105 ,H294156 H294204 ,H294254 ,H294304 ,H294352 ,H294401 ,H294449 ,H294502 ,H294008 ,H294057 H294106 ,H294157 ,H294205 ,H294255 ,H294305 ,H294353 ,H294402 ,H294450 ,H294503 H294009 ,H294058 ,H294107 ,H294158 ,H294206 ,H294256 ,H294306 ,H294354 ,H294403 H294451 ,H294504 ,H294010 ,H294059 ,H294108 ,H294159 ,H294207 ,H294257 ,H294307 H294355 ,H294404 ,H294452 ,H294505 ,H294011 ,H294060 ,H294109 ,H294160 ,H294208 H294258 ,H294308 ,H294356 ,H294405 ,H294454 ,H294506 ,H294507 ,H294555 ,H294614 H294666 ,H294719 ,H294775 ,H294832 ,H294901 ,H294508 ,H294556 ,H294615 ,H294667 H294720 ,H294777 ,H294833 ,H294902 ,H294509 ,H294564 ,H294616 ,H294668 ,H294721 H294778 ,H294834 ,H294904 ,H294510 ,H294565 ,H294617 ,H294670 ,H294723 ,H294779 H294835 ,H294906 ,H294511 ,H294567 ,H294618 ,H294671 ,H294724 ,H294780 ,H294836 H294907 ,H294512 ,H294568 ,H294619 ,H294673 ,H294726 ,H294781 ,H294838 ,H294908 H294513 ,H294569 ,H294620 ,H294674 ,H294727 ,H294782 ,H294839 ,H294910 ,H294514 H294570 ,H294621 ,H294675 ,H294728 ,H294783 ,H294840 ,H294914 ,H294515 ,H294571 H294623 ,H294676 ,H294729 ,H294784 ,H294841 ,H294915 ,H294516 ,H294572 ,H294624 H294677 ,H294730 ,H294786 ,H294842 ,H294917 ,H294517 ,H294573 ,H294625 ,H294678 H294731 ,H294787 ,H294843 ,H294918 ,H294518 ,H294574 ,H294626 ,H294679 ,H294732 H294790 ,H294845 ,H294919 ,H294519 ,H294575 ,H294627 ,H294680 ,H294733 ,H294792 H294846 ,H294921 ,H294520 ,H294576 ,H294628 ,H294681 ,H294735 ,H294793 ,H294847 H294922 ,H294521 ,H294577 ,H294629 ,H294682 ,H294736 ,H294794 ,H294848 ,H294923 H294522 ,H294579 ,H294630 ,H294683 ,H294737 ,H294795 ,H294850 ,H294924 ,H294523 H294580 ,H294632 ,H294684 ,H294738 ,H294796 ,H294851 ,H294926 ,H294524 ,H294581 H294633 ,H294685 ,H294739 ,H294797 ,H294853 ,H294928 ,H294525 ,H294582 ,H294634 H294686 ,H294740 ,H294798 ,H294855 ,H294929 ,H294526 ,H294583 ,H294635 ,H294687 H294742 ,H294799 ,H294856 ,H294930 ,H294527 ,H294584 ,H294636 ,H294688 ,H294743 H294800 ,H294858 ,H294932 ,H294528 ,H294585 ,H294637 ,H294689 ,H294744 ,H294801 H294859 ,H294933 ,H294529 ,H294586 ,H294639 ,H294690 ,H294745 ,H294802 ,H294860 H294934 ,H294530 ,H294587 ,H294640 ,H294692 ,H294746 ,H294803 ,H294861 ,H294936 H294531 ,H294588 ,H294641 ,H294693 ,H294747 ,H294804 ,H294862 ,H294937 ,H294532 H294589 ,H294642 ,H294694 ,H294748 ,H294805 ,H294863 ,H294945 ,H294533 ,H294590 H294643 ,H294695 ,H294749 ,H294806 ,H294864 ,H294950 ,H294534 ,H294591 ,H294644 H294696 ,H294750 ,H294807 ,H294865 ,H294951 ,H294535 ,H294592 ,H294645 ,H294697 H294751 ,H294808 ,H294867 ,Hcx4019 ,H294536 ,H294593 ,H294646 ,H294698 ,H294752 H294809 ,H294868 ,Hcx4138 ,H294537 ,H294594 ,H294647 ,H294700 ,H294753 ,H294810 H294871 ,Hcx4344 ,H294538 ,H294595 ,H294648 ,H294701 ,H294754 ,H294812 ,H294872 Hcx4400 ,H294539 ,H294597 ,H294649 ,H294702 ,H294755 ,H294813 ,H294874 ,Hcx4662 H294540 ,H294598 ,H294650 ,H294704 ,H294756 ,H294814 ,H294875 ,H294541 ,H294599 H294652 ,H294705 ,H294757 ,H294815 ,H294877 ,H294542 ,H294600 ,H294653 ,H294706 H294758 ,H294816 ,H294879 ,H294543 H294601 ,H294654 ,H294707 ,H294760 ,H294817 H294880 ,H294544 ,H294602 ,H294655 ,H294708 ,H294761 ,H294818 ,H294881 H294545 H294603 ,H294656 ,H294709 ,H294762 ,H294820 ,H294885 ,H294546 ,H294604 ,H294657 H294710 ,H294763 ,H294822 H294886 ,H294547 ,H294605 ,H294658 ,H294711 ,H294764 H294823 ,H294887 ,H294548 ,H294606 ,H294659 ,H294712 ,H294765 H294824 ,H294888 H294549 ,H294607 ,H294660 ,H294713 ,H294766 ,H294825 ,H294890 ,H294550 H294608, H294661 ,H294714 H294768 ,H294826 ,H294892 ,H294551 ,H294610 ,H294662 H294715, H294770 ,H294827 ,H294894 ,H294552 ,H294611 ,H294663 H294716, H294771, H294829, H294895, H294553, H294612, H294664, H294717, H294773, H294830, H294896, H294554, H294613, H294665, H294718, H294774, H294831, H294900
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 28, 2011. Firm initiated recall is ongoing.
REASON
Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.
VOLUME OF PRODUCT IN COMMERCE
5,616 units
DISTRIBUTION
Nationwide and Internationally
_______________________________________
PRODUCT
Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Recall # Z-2196-2011
CODE
Lot Number: 58946275
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences LLC, Draper, UT, by letter dated January 21, 2011. Firm initiated recall is complete.
REASON
Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7. Part Numbers: 22-10-0118, 22-10-0120, 22-10-0122, 22-10-0124, 22-10-0126, 22-10-0128, 22-10-0130, 22-10-0132, 22-10-0134, 22-10-0231, 22-10-0234, 22-10-0237, 22-10-0240, 22-10-0243, 22-10-0246, 22-10-0249, 22-10-0252, 22-10-348, 22-10-0351, 22-10-0354, 22-10-0357, 22-10-0360, 22-10-0363, 22-10-0366, 22-10-0369, 22-10-0372, 22-10-0375, 22-10-0468, 22-10-0472, 22-10-0476, 22-10-0480, 22-10-0484, 22-10-0488, 22-12-4014, 22-12-4015, 22-12-4016, 22-12-018, 22-13-4513, 22-13-4515, 22-13-4517, 22-14-4513, 22-14-4515, 22-14-4517, 22-15-4010, 22-15-4012, 22-15-4013, 22-15-4014, 22-15-4015, 22-15-4016, 22-5-4018, 22-16-4010, 22-16-4012, 22-16-4013, 22-16-4014, 22-16-4015, 22-16-4016, 22-16-4018, 22-17-4513, 22-17-4515, 22-17-4517, 22-18-4513, 22-18-4515, 22-18-4517, 22-20-0118, 22-20-0120, 22-20-0122, 22-20-0124, 22-20-0126, 22-20-0128, 22-20-0130, 22-20-0132, 22-20-0134, 22-20-0231, 22-20-0234, 22-20-0237, 22-20-0240, 22-20-0243, 22-20-0246, 22-20-0249, 22-20-0252, 22-20-0348, 22-20-0351, 22-20-0354, 22-20-0357, 22-20-0360, 22-20-0363, 22-20-0366, 22-20-0369, 22-20-0372, 22-20-0375, 22-20-0468, 22-20-0472, 22-20-0476, 22-20-0480, 22-20-0484, 22-20-0488, 22-20-0492, 22-21-4010, 22-21-4011, 22-21-4012, 22-21-4013 & 22-21-4014. Recall # Z-2197-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated January 10, 2011.
Manufacturer: Theken Spine LLC, Akron, OH. Firm initiated recall is ongoing.
REASON
The Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional warnings, precautions and possible adverse events.
VOLUME OF PRODUCT IN COMMERCE
244 IFU
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. Recall # Z-2214-2011
CODE
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RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letters dated January 19, 2011 and March 11, 2011.
Manufacturers: Ge Hangwei Medical Systems Co., Ltd., Beijing, China;
Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan.
Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.
VOLUME OF PRODUCT IN COMMERCE
479 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies. Recall # Z-2215-2011
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 18, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable range of the assay. When customers interchange between diluents there is an unacceptable shift in results. A median difference of 16% (ranging from 14% to 23%) between Wash Buffer II (revised diluent) and Thyroglobulin Sample Diluent(current diluent) was observed.
VOLUME OF PRODUCT IN COMMERCE
6,414 units
DISTRIBUTION
Nationwide and Canada
_______________________________________
PRODUCT
ARTISTE, ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. Intended use: Radiation therapy. Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754. Recall # Z-2216-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 31, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review.
VOLUME OF PRODUCT IN COMMERCE
45 active devices
DISTRIBUTION
Nationwide, Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom
___________________________________
PRODUCT
Eclipse Treatment Planning System, Client software versions 8.0 through 8.6; Model Number: H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Recall # Z-2220-2011
CODE
Serial Numbers: H480005, H480079, H480156, H480251, H480365, H480436, H480573,  H480647 ,H480750 ,H480883 ,H480996 ,H480006 ,H480080 ,H480157 ,H480252 ,H480369 ,H480437 ,H480574 ,H480648 ,H480751 ,H480884 ,H480997 ,H480007 ,H480081 ,H480158 ,H480253 ,H480370 ,H480438 ,H480575 ,H480651 ,H480755 ,H480886 ,H480998 ,H480008 ,H480082 ,H480169 ,H480254 ,H480371 ,H480439 ,H480576 ,H480653 ,H480757 ,H480887 ,H480999 ,H480009 ,H480083 ,H480170 ,H480255 ,H480372 ,H480440 ,H480583 ,H480654 ,H480758 ,H480890 ,H481000 ,H480010 ,H480084 ,H480172 ,H480256 ,H480373 ,H480441 ,H480585 ,H480655 ,H480759 ,H480892 ,H481002 ,H480011 ,H480085 ,H480173 ,H480257 ,H480374 ,H480461 ,H480586 ,H480656 ,H480772 ,H480898 ,H481005 ,H480012 ,H480086 ,H480178 ,H480265 ,H480375 ,H480462 ,H480587 ,H480657 ,H480774 ,H480899 ,H481006 ,H480013 ,H480087 ,H480180 ,H480277 ,H480376 ,H480463 ,H480592 ,H480658 ,H480775 ,H480901 ,H481007 ,H480014 ,H480088 ,H480181 ,H480281 ,H480377 ,H480467 ,H480593 ,H480660 ,H480779 ,H480902 ,H481008 ,H480023 ,H480089 ,H480187 ,H480282 ,H480382 ,H480468 ,H480596 ,H480661 ,H480780 ,H480903 ,H481009 ,H480024 ,H480090 ,H480188 ,H480287 ,H480383 ,H480469 ,H480599 ,H480663 ,H480781 ,H480913 ,H481010 ,H480025 ,H480091 ,H480189 ,H480294 ,H480384 ,H480471 ,H480600 ,H480665 ,H480788 ,H480915 ,H481022 ,H480026 ,H480095 ,H480190 ,H480297 ,H480388 ,H480473 ,H480601 ,H480667 ,H480789 ,H480927 ,H481023 ,H480027 ,H480096 ,H480191 ,H480298 ,H480389 ,H480474 ,H480602 ,H480672 ,H480790 ,H480936 ,H481024 ,H480028 ,H480105 ,H480192 ,H480300 ,H480390 ,H480475 ,H480603 ,H480673 ,H480791 ,H480939 ,H481025 ,H480030 ,H480106 ,H480193 ,H480303 ,H480391 ,H480476 ,H480604 ,H480674 ,H480792 ,H480940 ,H481026 ,H480031 ,H480112 ,H480194 ,H480305 ,H480392 ,H480481 ,H480605 ,H480675 ,H480796 ,H480941 ,H481027 ,H480032 ,H480113 ,H480195 ,H480306 ,H480393 ,H480482 ,H480610 ,H480676 ,H480797 ,H480942 ,H481028 ,H480033 ,H480115 ,H480196 ,H480307 ,H480394 ,H480486 ,H480611 ,H480677 ,H480798 ,H480943 ,H481029 ,H480034 ,H480118 ,H480197 ,H480308 ,H480395 ,H480487 ,H480612 ,H480678 ,H480799 ,H480944 ,H481030 ,H480035 ,H480119 ,H480198 ,H480311 ,H480396 ,H480488 ,H480613 ,H480679 ,H480802 ,H480947 ,H481031 ,H480036 ,H480121 ,H480199 ,H480312 ,H480397 ,H480489 ,H480614 ,H480680 ,H480808 ,H480948 ,H481032 ,H480037 ,H480122 ,H480201 ,H480313 ,H480398 ,H480490 ,H480616 ,H480682 ,H480809 ,H480949 ,H481037 ,H480038 ,H480123 ,H480202 ,H480314 ,H480399 ,H480491 ,H480617 ,H480683 ,H480810 ,H480950 ,H481038 ,H480039 ,H480124 ,H480203 ,H480315 ,H480403 ,H480492 ,H480618 ,H480684 ,H480811 ,H480952 ,H481054 ,H480040 ,H480125 ,H480204 ,H480318 ,H480404 ,H480494 ,H480619 ,H480699 ,H480812 ,H480953 ,H481055 ,H480042 ,H480126 ,H480205 ,H480319 ,H480405 ,H480495 ,H480620 ,H480700 ,H480813 ,H480954 ,H481056 ,H480046 ,H480127 ,H480206 ,H480323 ,H480406 ,H480496 ,H480621 ,H480701 ,H480815 ,H480955 ,H481062 ,H480047 ,H480129 ,H480211 ,H480324 ,H480408 ,H480497 ,H480626 ,H480705 ,H480827 ,H480956 ,H481063 ,H480048 ,H480131 ,H480212 ,H480325 ,H480409 ,H480498 ,H480627 ,H480707 ,H480828 ,H480957 ,H481071 ,H480051 ,H480132 ,H480213 ,H480326 ,H480410 ,H480502 ,H480628 ,H480708 ,H480829 ,H480958 ,H481077 ,H480052 ,H480137 ,H480214 ,H480327 ,H480411 ,H480503 ,H480629 ,H480709 ,H480830 ,H480959 ,H481078 ,H480053 ,H480138 ,H480215 ,H480328 ,H480412 ,H480504 ,H480630 ,H480710 ,H480831 ,H480960 ,H481092 ,H480054 ,H480139 ,H480216 ,H480329 ,H480413 ,H480505 ,H480631 ,H480711 ,H480832 ,H480962 ,H481093 ,H480055 ,H480141 ,H480219 ,H480330 ,H480414 ,H480513 ,H480632 ,H480718 ,H480855 ,H480965 ,H481094 ,H480056 ,H480143 ,H480221 ,H480331 ,H480415 ,H480514 ,H480633 ,H480729 ,H480856 ,H480966 ,H481095 ,H480057 ,H480144 ,H480222 ,H480332 ,H480416 ,H480518 ,H480634 ,H480732 ,H480857 ,H480980 ,H481096 ,H480058 ,H480145 ,H480223 ,H480333 ,H480417 ,H480519 ,H480635 ,H480733 ,H480858 ,H480982 ,H481097 ,H480059 ,H480146 ,H480224 ,H480334 ,H480418 ,H480529 ,H480636 ,H480734 ,H480859 ,H480983 ,H481099 ,H480060 ,H480147 ,H480236 ,H480335 ,H480419 ,H480539 ,H480637 ,H480735 ,H480860 ,H480984 ,H481100 ,H480061 ,H480148 ,H480237 ,H480339 ,H480420 ,H480541 ,H480638 ,H480739 ,H480861 ,H480985 ,H481101 ,H480062 ,H480149 ,H480245 ,H480346 ,H480421 ,H480547 ,H480640 ,H480740 ,H480862 ,H480986 ,H481102 ,H480063 ,H480150 ,H480246 ,H480347 ,H480423 ,H480548 ,H480641 ,H480745 ,H480863 ,H480987 ,H481103 ,H480064 ,H480152 ,H480247 ,H480355 ,H480424 ,H480549 ,H480642 ,H480746 ,H480869 ,H480988 ,H481108 ,H480065 ,H480153 ,H480248 ,H480356 ,H480433 ,H480570 ,H480643 ,H480747 ,H480870 ,H480989 ,H481114 ,H480066 ,H480154 ,H480249 ,H480357 ,H480434 ,H480571 ,H480644 ,H480748 ,H480876 ,H480992 ,H481115 ,H480078 ,H480155 ,H480250 ,H480361 ,H480435 ,H480572 ,H480646 ,H480749 ,H480881 ,H480994 ,H481116 ,H481117 ,H481267 ,H481348 ,H481502 ,H481640 ,H481739 ,H481870 ,H481968 ,H482019 ,H482070 ,H482143 ,H481118 ,H481268 ,H481349 ,H481503 ,H481644 ,H481740 ,H481871 ,H481969 ,H482020 ,H482071 ,H482144 ,H481122 ,H481269 ,H481358 ,H481504 ,H481645 ,H481741 ,H481872 ,H481970 ,H482021 ,H482072 ,H482145 ,H481123 ,H481270 ,H481359 ,H481505 ,H481646 ,H481742 ,H481873 ,H481971 ,H482022 ,H482073 ,H482146 ,H481124 ,H481271 ,H481360 ,H481506 ,H481647 ,H481743 ,H481874 ,H481972 ,H482023 ,H482074 ,H482147 ,H481125 ,H481272 ,H481361 ,H481508 ,H481648 ,H481750 ,H481875 ,H481973 ,H482024 ,H482075 ,H482156 ,H481126 ,H481273 ,H481362 ,H481509 ,H481649 ,H481757 ,H481876 ,H481974 ,H482025 ,H482076 ,H482157 ,H481127 ,H481274 ,H481363 ,H481510 ,H481650 ,H481758 ,H481879 ,H481975 ,H482026 ,H482077 ,H482160 ,H481128 ,H481275 ,H481366 ,H481513 ,H481651 ,H481759 ,H481884 ,H481976 ,H482027 ,H482078 ,H482161 ,H481129 ,H481276 ,H481367 ,H481514 ,H481652 ,H481760 ,H481885 ,H481977 ,H482028 ,H482079 ,H482164 ,H481133 ,H481277 ,H481373 ,H481515 ,H481653 ,H481761 ,H481886 ,H481978 ,H482029 ,H482080 ,H482165 ,H481134 ,H481278 ,H481381 ,H481517 ,H481654 ,H481762 ,H481889 ,H481979 ,H482030 ,H482081 ,H482172 ,H481136 ,H481279 ,H481382 ,H481518 ,H481655 ,H481774 ,H481890 ,H481980 ,H482031 ,H482082 ,H482178 ,H481143 ,H481280 ,H481383 ,H481519 ,H481656 ,H481777 ,H481891 ,H481981 ,H482032 ,H482083 ,H482181 ,H481144 ,H481281 ,H481391 ,H481520 ,H481657 ,H481778 ,H481893 ,H481982 ,H482033 ,H482084 ,H482182 ,H481153 ,H481282 ,H481392 ,H481521 ,H481658 ,H481779 ,H481894 ,H481983 ,H482034 ,H482085 ,H482183 ,H481154 ,H481283 ,H481393 ,H481522 ,H481659 ,H481780 ,H481896 ,H481984 ,H482035 ,H482086 ,H482185 ,H481155 ,H481284 ,H481394 ,H481523 ,H481662 ,H481781 ,H481897 ,H481985 ,H482036 ,H482087 ,H482186 ,H481156 ,H481285 ,H481395 ,H481525 ,H481663 ,H481783 ,H481898 ,H481986 ,H482037 ,H482088 ,H482187 ,H481157 ,H481286 ,H481397 ,H481530 ,H481664 ,H481784 ,H481899 ,H481987 ,H482038 ,H482089 ,H482188 ,H481158 ,H481287 ,H481398 ,H481531 ,H481665 ,H481787 ,H481909 ,H481988 ,H482039 ,H482090 ,H482194 ,H481159 ,H481288 ,H481399 ,H481540 ,H481666 ,H481788 ,H481916 ,H481989 ,H482040 ,H482091 ,H482195 ,H481160 ,H481289 ,H481401 ,H481542 ,H481669 ,H481793 ,H481918 ,H481990 ,H482041 ,H482092 ,H482198 ,H481169 ,H481290 ,H481402 ,H481547 ,H481678 ,H481794 ,H481919 ,H481991 ,H482042 ,H482093 ,H482201 ,H481184 ,H481291 ,H481408 ,H481548 ,H481679 ,H481798 ,H481920 ,H481992 ,H482043 ,H482094 ,H482203 ,H481188 ,H481292 ,H481409 ,H481549 ,H481680 ,H481799 ,H481923 ,H481993 ,H482044 ,H482095 ,H482209 ,H481193 ,H481293 ,H481410 ,H481551 ,H481681 ,H481800 ,H481924 ,H481994 ,H482045 ,H482096 ,H482210 ,H481194 ,H481294 ,H481411 ,H481558 ,H481682 ,H481801 ,H481925 ,H481995 ,H482046 ,H482097 ,H482211 ,H481195 ,H481295 ,H481412 ,H481560 ,H481683 ,H481810 ,H481926 ,H481996 ,H482047 ,H482098 ,H482212 ,H481203 ,H481296 ,H481419 ,H481561 ,H481684 ,H481812 ,H481927 ,H481997 ,H482048 ,H482099 ,H482213 ,H481204 ,H481298 ,H481428 ,H481562 ,H481685 ,H481813 ,H481928 ,H481998 ,H482049 ,H482100 ,H482214 ,H481214 ,H481300 ,H481432 ,H481563 ,H481689 ,H481814 ,H481929 ,H481999 ,H482050 ,H482101 ,H482215 ,H481220 ,H481301 ,H481434 ,H481564 ,H481690 ,H481818 ,H481930 ,H482000 ,H482051 ,H482102 ,H482225 ,H481221 ,H481308 ,H481435 ,H481565 ,H481692 ,H481820 ,H481931 ,H482001 ,H482052 ,H482103 ,H482226 ,H481223 ,H481311 ,H481442 ,H481585 ,H481707 ,H481828 ,H481932 ,H482002 ,H482053 ,H482104 ,H482229 ,H481224 ,H481315 ,H481443 ,H481586 ,H481716 ,H481829 ,H481933 ,H482003 ,H482054 ,H482105 ,H482239 ,H481225 ,H481316 ,H481445 ,H481587 ,H481718 ,H481830 ,H481934 ,H482004 ,H482055 ,H482106 ,H482242 ,H481226 ,H481317 ,H481455 ,H481588 ,H481719 ,H481831 ,H481936 ,H482005 ,H482056 ,H482107 ,H482250 ,H481227 ,H481318 ,H481456 ,H481589 ,H481720 ,H481832 ,H481953 ,H482006 ,H482057 ,H482108 ,H482251 ,H481228 ,H481320 ,H481457 ,H481606 ,H481722 ,H481833 ,H481956 ,H482007 ,H482058 ,H482109 ,H482252 ,H481229 ,H481321 ,H481458 ,H481610 ,H481723 ,H481836 ,H481957 ,H482008 ,H482059 ,H482110 ,H482253 ,H481230 ,H481328 ,H481459 ,H481611 ,H481727 ,H481837 ,H481958 ,H482009 ,H482060 ,H482111 ,H482254 ,H481231 ,H481329 ,H481465 ,H481612 ,H481728 ,H481838 ,H481959 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,H488380 ,H488460 ,H488558 ,H488631 ,H488687 ,H488775 ,H488874 ,H488945 ,H489039 ,H489113 ,H488302 ,H488381 ,H488461 ,H488559 ,H488633 ,H488688 ,H488776 ,H488875 ,H488951 ,H489040 ,H489114 ,H488303 ,H488382 ,H488469 ,H488560 ,H488636 ,H488689 ,H488779 ,H488876 ,H488953 ,H489041 ,H489121 ,H488304 ,H488383 ,H488470 ,H488561 ,H488637 ,H488690 ,H488780 ,H488877 ,H488955 ,H489042 ,H489125 ,H488305 ,H488384 ,H488471 ,H488564 ,H488638 ,H488691 ,H488782 ,H488878 ,H488956 ,H489043 ,H489126 ,H488306 ,H488385 ,H488472 ,H488565 ,H488639 ,H488692 ,H488783 ,H488879 ,H488957 ,H489046 ,H489127 ,H488307 ,H488387 ,H488473 ,H488569 ,H488640 ,H488693 ,H488784 ,H488880 ,H488958 ,H489047 ,H489128 ,H488308 ,H488388 ,H488474 ,H488570 ,H488641 ,H488694 ,H488785 ,H488881 ,H488959 ,H489053 ,H489130 ,H488309 ,H488389 ,H488475 ,H488573 ,H488642 ,H488695 ,H488786 ,H488882 ,H488960 ,H489054 ,H489131 ,H488310 ,H488390 ,H488476 ,H488574 ,H488643 ,H488696 ,H488787 ,H488883 ,H488961 ,H489055 ,H489132 ,H488311 ,H488391 ,H488477 ,H488575 ,H488644 ,H488699 ,H488788 ,H488884 ,H488962 ,H489056 ,H489133 ,H488312 ,H488394 ,H488478 ,H488576 ,H488645 ,H488703 ,H488792 ,H488885 ,H488963 ,H489060 ,H489134 ,H488313 ,H488397 ,H488481 ,H488577 ,H488646 ,H488704 ,H488793 ,H488886 ,H488969 ,H489062 ,H489136 ,H488316 ,H488399 ,H488483 ,H488578 ,H488647 ,H488705 ,H488795 ,H488887 ,H488972 ,H489063 ,H489138 ,H488320 ,H488401 ,H488488 ,H488579 ,H488648 ,H488706 ,H488796 ,H488888 ,H488973 ,H489064 ,H489139 ,H488321 ,H488403 ,H488489 ,H488585 ,H488649 ,H488707 ,H488798 ,H488889 ,H488981 ,H489065 ,H489149 ,H488322 ,H488404 ,H488490 ,H488586 ,H488650 ,H488708 ,H488799 ,H488890 ,H488982 ,H489066 ,H489150 ,H488323 ,H488408 ,H488491 ,H488587 ,H488651 ,H488709 ,H488801 ,H488891 ,H488983 ,H489067 ,H489151 ,H488324 ,H488409 ,H488492 ,H488588 ,H488652 ,H488710 ,H488804 ,H488892 ,H488985 ,H489068 ,H489152 ,H488325 ,H488412 ,H488493 ,H488589 ,H488653 ,H488711 ,H488805 ,H488893 ,H488986 ,H489069 ,H489153 ,H488326 ,H488413 ,H488494 ,H488590 ,H488654 ,H488714 ,H488809 ,H488894 ,H488987 ,H489070 ,H489154 ,H488327 ,H488414 ,H488495 ,H488591 ,H488655 ,H488715 ,H488811 ,H488895 ,H488988 ,H489071 ,H489155 ,H488328 ,H488415 ,H488496 ,H488592 ,H488656 ,H488720 ,H488820 ,H488896 ,H488991 ,H489072 ,H489162 ,H488329 ,H488416 ,H488497 ,H488593 ,H488657 ,H488722 ,H488821 ,H488897 ,H488992 ,H489073 ,H489163 ,H488330 ,H488417 ,H488498 ,H488594 ,H488658 ,H488724 ,H488822 ,H488899 ,H488993 ,H489075 ,H489164 ,H488331 ,H488418 ,H488499 ,H488595 ,H488659 ,H488729 ,H488826 ,H488900 ,H488994 ,H489076 ,H489166 ,H488332 ,H488419 ,H488507 ,H488596 ,H488660 ,H488730 ,H488827 ,H488901 ,H488995 ,H489077 ,H489167 ,H488336 ,H488420 ,H488512 ,H488597 ,H488661 ,H488731 ,H488828 ,H488902 ,H489000 ,H489078 ,H489168 ,H488337 ,H488421 ,H488513 ,H488598 ,H488662 ,H488732 ,H488830 ,H488903 ,H489001 ,H489080 ,H489169 ,H488350 ,H488422 ,H488514 ,H488599 ,H488663 ,H488736 ,H488831 ,H488906 ,H489003 ,H489081 ,H489170 ,H488351 ,H488424 ,H488515 ,H488600 ,H488664 ,H488738 ,H488832 ,H488912 ,H489004 ,H489082 ,H489181 ,H488352 ,H488425 ,H488520 ,H488601 ,H488665 ,H488739 ,H488833 ,H488920 ,H489005 ,H489083 ,H489184 ,H488353 ,H488426 ,H488521 ,H488602 ,H488666 ,H488740 ,H488850 ,H488921 ,H489006 ,H489084 ,H489185 ,H488354 ,H488427 ,H488525 ,H488603 ,H488667 ,H488741 ,H488851 ,H488922 ,H489009 ,H489085 ,H489186 ,H488355 ,H488431 ,H488526 ,H488612 ,H488668 ,H488742 ,H488852 ,H488923 ,H489017 ,H489086 ,H489187 ,H488356 ,H488438 ,H488527 ,H488613 ,H488669 ,H488743 ,H488853 ,H488924 ,H489018 ,H489087 ,H489188 ,H488357 ,H488439 ,H488528 ,H488614 ,H488672 ,H488744 ,H488854 ,H488925 ,H489019 ,H489089 ,H489192 ,H488358 ,H488440 ,H488529 ,H488615 ,H488673 ,H488746 ,H488855 ,H488926 ,H489020 ,H489091 ,H489193 ,H488359 ,H488441 ,H488530 ,H488616 ,H488674 ,H488747 ,H488857 ,H488929 ,H489024 ,H489092 ,H489195 ,H488360 ,H488442 ,H488532 ,H488617 ,H488675 ,H488749 ,H488858 ,H488930 ,H489025 ,H489093 ,H489196 ,H488361 ,H488446 ,H488533 ,H488618 ,H488676 ,H488756 ,H488859 ,H488931 ,H489026 ,H489094 ,H489197 ,H488362 ,H488447 ,H488534 ,H488619 ,H488677 ,H488757 ,H488861 ,H488932 ,H489027 ,H489100 ,H489199 ,H489200 ,H489303 ,H489357 ,H489419 ,H489487 ,H489555 ,H489637 ,H489709 ,H489803 ,H489883 ,H48A000 ,H489201 ,H489304 ,H489358 ,H489420 ,H489488 ,H489556 ,H489638 ,H489710 ,H489804 ,H489884 ,H48A024 ,H489203 ,H489305 ,H489359 ,H489421 ,H489489 ,H489557 ,H489646 ,H489711 ,H489805 ,H489886 ,H48A025 ,H489204 ,H489306 ,H489360 ,H489422 ,H489490 ,H489558 ,H489647 ,H489712 ,H489806 ,H489890 ,H48A026 ,H489205 ,H489307 ,H489361 ,H489423 ,H489491 ,H489559 ,H489648 ,H489713 ,H489807 ,H489891 ,H48A027 ,H489206 ,H489308 ,H489362 ,H489424 ,H489492 ,H489560 ,H489657 ,H489714 ,H489808 ,H489898 ,H48A028 ,H489207 ,H489309 ,H489363 ,H489434 ,H489493 ,H489563 ,H489658 ,H489715 ,H489809 ,H489899 ,H48A032 ,H489208 ,H489310 ,H489364 ,H489435 ,H489494 ,H489565 ,H489659 ,H489716 ,H489810 ,H489911 ,H48A033 ,H489209 ,H489311 ,H489365 ,H489436 ,H489495 ,H489566 ,H489660 ,H489718 ,H489812 ,H489912 ,H48A034 ,H489210 ,H489312 ,H489366 ,H489437 ,H489496 ,H489568 ,H489661 ,H489719 ,H489813 ,H489913 ,H48A035 ,H489211 ,H489313 ,H489367 ,H489438 ,H489497 ,H489569 ,H489662 ,H489720 ,H489814 ,H489916 ,H48A036 ,H489212 ,H489314 ,H489368 ,H489439 ,H489498 ,H489570 ,H489664 ,H489724 ,H489815 ,H489917 ,H48A037 ,H489213 ,H489315 ,H489369 ,H489442 ,H489499 ,H489571 ,H489665 ,H489725 ,H489818 ,H489919 ,H48A039 ,H489214 ,H489316 ,H489370 ,H489443 ,H489506 ,H489573 ,H489666 ,H489729 ,H489819 ,H489920 ,H48A041 ,H489215 ,H489317 ,H489371 ,H489444 ,H489507 ,H489574 ,H489667 ,H489730 ,H489825 ,H489927 ,H48A042 ,H489216 ,H489318 ,H489376 ,H489445 ,H489508 ,H489575 ,H489668 ,H489731 ,H489826 ,H489933 ,H48A043 ,H489217 ,H489319 ,H489377 ,H489446 ,H489510 ,H489576 ,H489669 ,H489732 ,H489831 ,H489934 ,H48A047 ,H489219 ,H489320 ,H489378 ,H489447 ,H489511 ,H489579 ,H489670 ,H489733 ,H489834 ,H489935 ,H48A048 ,H489220 ,H489321 ,H489380 ,H489452 ,H489515 ,H489580 ,H489671 ,H489734 ,H489835 ,H489936 ,H48A049 ,H489221 ,H489322 ,H489381 ,H489453 ,H489516 ,H489581 ,H489672 ,H489735 ,H489836 ,H489937 ,H48A050 ,H489222 ,H489323 ,H489382 ,H489454 ,H489517 ,H489582 ,H489673 ,H489736 ,H489844 ,H489938 ,H48A051 ,H489228 ,H489324 ,H489383 ,H489455 ,H489518 ,H489583 ,H489674 ,H489737 ,H489845 ,H489939 ,H48A054 ,H489230 ,H489325 ,H489384 ,H489456 ,H489519 ,H489584 ,H489675 ,H489740 ,H489846 ,H489940 ,H48A055 ,H489231 ,H489326 ,H489385 ,H489457 ,H489520 ,H489585 ,H489676 ,H489741 ,H489847 ,H489941 ,H48A057 ,H489232 ,H489327 ,H489387 ,H489458 ,H489521 ,H489586 ,H489677 ,H489742 ,H489850 ,H489942 ,H48A058 ,H489243 ,H489328 ,H489389 ,H489459 ,H489522 ,H489588 ,H489678 ,H489744 ,H489851 ,H489948 ,H48A059 ,H489244 ,H489329 ,H489390 ,H489460 ,H489523 ,H489589 ,H489679 ,H489745 ,H489856 ,H489949 ,H48A060 ,H489245 ,H489330 ,H489391 ,H489461 ,H489524 ,H489590 ,H489681 ,H489746 ,H489857 ,H489952 ,H48A062 ,H489246 ,H489331 ,H489392 ,H489462 ,H489525 ,H489591 ,H489682 ,H489747 ,H489858 ,H489954 ,H48A063 ,H489251 ,H489332 ,H489393 ,H489463 ,H489526 ,H489592 ,H489683 ,H489754 ,H489859 ,H489956 ,H48A064 ,H489252 ,H489333 ,H489394 ,H489464 ,H489527 ,H489593 ,H489684 ,H489755 ,H489860 ,H489957 ,H48A065 ,H489253 ,H489334 ,H489395 ,H489465 ,H489530 ,H489594 ,H489685 ,H489756 ,H489861 ,H489958 ,H48A066 ,H489254 ,H489335 ,H489396 ,H489466 ,H489531 ,H489595 ,H489686 ,H489757 ,H489862 ,H489959 ,H48A068 ,H489255 ,H489336 ,H489397 ,H489467 ,H489532 ,H489598 ,H489688 ,H489758 ,H489864 ,H489961 ,H48A069 ,H489256 ,H489337 ,H489398 ,H489468 ,H489533 ,H489600 ,H489689 ,H489760 ,H489865 ,H489962 ,H48A070 ,H489260 ,H489338 ,H489399 ,H489469 ,H489534 ,H489601 ,H489691 ,H489767 ,H489866 ,H489963 ,H48A074 ,H489261 ,H489340 ,H489401 ,H489470 ,H489535 ,H489602 ,H489692 ,H489768 ,H489867 ,H489964 ,H48A075 ,H489262 ,H489341 ,H489402 ,H489471 ,H489536 ,H489603 ,H489694 ,H489780 ,H489868 ,H489965 ,H48A076 ,H489269 ,H489342 ,H489403 ,H489472 ,H489537 ,H489604 ,H489695 ,H489781 ,H489869 ,H489966 ,H48A077 ,H489270 ,H489343 ,H489404 ,H489473 ,H489538 ,H489605 ,H489696 ,H489782 ,H489870 ,H489970 ,H48A078 ,H489290 ,H489344 ,H489405 ,H489474 ,H489539 ,H489616 ,H489697 ,H489783 ,H489871 ,H489971 ,H48A079 ,H489291 ,H489346 ,H489406 ,H489475 ,H489540 ,H489617 ,H489698 ,H489784 ,H489872 ,H489972 ,H48A080 ,H489292 ,H489347 ,H489407 ,H489476 ,H489541 ,H489619 ,H489699 ,H489785 ,H489873 ,H489973 ,H48A081 ,H489293 ,H489348 ,H489408 ,H489478 ,H489542 ,H489620 ,H489700 ,H489788 ,H489874 ,H489974 ,H48A082 ,H489296 ,H489349 ,H489409 ,H489479 ,H489543 ,H489621 ,H489701 ,H489789 ,H489875 ,H489975 ,H48A106 ,H489297 ,H489350 ,H489410 ,H489480 ,H489544 ,H489629 ,H489702 ,H489790 ,H489876 ,H489976 ,H48A107 ,H489298 ,H489351 ,H489411 ,H489482 ,H489545 ,H489630 ,H489703 ,H489798 ,H489877 ,H489977 ,H48A108 ,H489299 ,H489352 ,H489412 ,H489483 ,H489546 ,H489633 ,H489704 ,H489799 ,H489878 ,H489981 ,H48A111 ,H489300 ,H489353 ,H489413 ,H489484 ,H489552 ,H489634 ,H489706 ,H489800 ,H489879 ,H489982 ,H48A112 ,H489301 ,H489354 ,H489414 ,H489485 ,H489553 ,H489635 ,H489707 ,H489801 ,H489880 ,H489990 ,H48A113 ,H489302 ,H489356 ,H489418 ,H489486 ,H489554 ,H489636 ,H489708 ,H489802 ,H489881 ,H489997 ,H48A114 ,H48A115 ,H48A358 ,H48A554 ,H48A888 ,H48B390 ,H48B791 ,H48A116 ,H48A360 ,H48A557 ,H48A896 ,H48B391 ,H48B804 ,H48A117 ,H48A362 ,H48A587 ,H48A912 ,H48B392 ,H48B805 ,H48A118 ,H48A363 ,H48A606 ,H48A913 ,H48B417 ,H48B806 ,H48A119 ,H48A364 ,H48A640 ,H48A914 ,H48B418 ,H48B807 ,H48A125 ,H48A365 ,H48A641 ,H48A915 ,H48B423 ,H48B808 ,H48A126 ,H48A366 ,H48A642 ,H48A916 ,H48B426 ,H48B809 ,H48A127 ,H48A367 ,H48A643 ,H48A917 ,H48B451 ,H48B810 ,H48A128 ,H48A374 ,H48A644 ,H48A960 ,H48B481 ,H48B817 ,H48A136 ,H48A375 ,H48A648 ,H48A961 ,H48B482 ,H48B820 ,H48A160 ,H48A376 ,H48A649 ,H48A962 ,H48B570 ,H48B843 ,H48A165 ,H48A377 ,H48A650 ,H48A972 ,H48B571 ,H48B900 ,H48A166 ,H48A378 ,H48A651 ,H48A988 ,H48B572 ,H48B937 ,H48A167 ,H48A379 ,H48A669 ,H48A991 ,H48B575 ,H48B938 ,H48A168 ,H48A380 ,H48A670 ,H48A992 ,H48B576 ,H48B939 ,H48A169 ,H48A381 ,H48A671 ,H48B007 ,H48B577 ,H48C018 ,H48A177 ,H48A382 ,H48A675 ,H48B008 ,H48B584 ,H48C022 ,H48A180 ,H48A383 ,H48A682 ,H48B009 ,H48B585 ,H48A181 ,H48A384 ,H48A685 ,H48B010 ,H48B619 ,H48A185 ,H48A385 ,H48A686 ,H48B011 ,H48B651 ,H48A194 ,H48A386 ,H48A687 ,H48B030 ,H48B664 ,H48A195 ,H48A387 ,H48A688 ,H48B031 ,H48B668 ,H48A204 ,H48A391 ,H48A689 ,H48B032 ,H48B669 ,H48A205 ,H48A392 ,H48A692 ,H48B033 ,H48B670 ,H48A209 ,H48A393 ,H48A693 ,H48B034 ,H48B671 ,H48A210 ,H48A406 ,H48A696 ,H48B043 ,H48B672 ,H48A213 ,H48A410 ,H48A697 ,H48B088 ,H48B673 ,H48A214 ,H48A411 ,H48A711 ,H48B091 ,H48B674 ,H48A215 ,H48A412 ,H48A760 ,H48B209 ,H48B675 ,H48A217 ,H48A413 ,H48A761 ,H48B210 ,H48B676 ,H48A231 ,H48A414 ,H48A775 ,H48B213 ,H48B677 ,H48A246 ,H48A422 ,H48A776 ,H48B214 ,H48B678 ,H48A253 ,H48A442 ,H48A777 ,H48B215 ,H48B679 ,H48A256 ,H48A443 ,H48A783 ,H48B218 ,H48B680 ,H48A257 ,H48A448 ,H48A784 ,H48B221 ,H48B681 ,H48A258 ,H48A454 ,H48A785 ,H48B222 ,H48B682 ,H48A267 ,H48A455 ,H48A794 ,H48B243 ,H48B683 ,H48A268 ,H48A456 ,H48A811 ,H48B244 ,H48B684 ,H48A269 ,H48A470 ,H48A815 ,H48B245 ,H48B685 ,H48A287 ,H48A471 ,H48A823 ,H48B246 ,H48B686 ,H48A288 ,H48A472 ,H48A824 ,H48B248 ,H48B687 ,H48A291 ,H48A480 ,H48A825 ,H48B249 ,H48B688 ,H48A292 ,H48A491 ,H48A837 ,H48B257 ,H48B689 ,H48A293 ,H48A492 ,H48A843 ,H48B258 ,H48B690 ,H48A294 ,H48A493 ,H48A844 ,H48B259 ,H48B762 ,H48A305 ,H48A494 ,H48A853 ,H48B260 ,H48B763 ,H48A306 ,H48A501 ,H48A863 ,H48B261 ,H48B764 ,H48A316 ,H48A532 ,H48A864 ,H48B288 ,H48B765 ,H48A322 ,H48A533 ,H48A865 ,H48B365 ,H48B788 ,H48A356 ,H48A535 ,H48A869 ,H48B376 ,H48B789 ,H48A357 ,H48A543 ,H48A870 ,H48B389 ,H48B790
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 4, 2011. Firm initiated recall is ongoing.
REASON
An anomaly in Eclipse Treatment Planning System, versions 8.0 to 8.6, whereby Actual SSD (source surface distance) value may not correspond to the Planned SSD value after Planning Approval.
VOLUME OF PRODUCT IN COMMERCE
5,288 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90. 204589 Robot Arm Label***PN 203999 SN ROB XXX 2011-01.***V 100/120/230 A 9.6/8.0/4.2 Hz 50/60***Weight 39.4kg***Class I Equipment Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1:2003 CAN/CSA-C22.2 No. 601-1-M90. 204588 Label With Guidance Module Number***PN 201251 SN GUD XXX 2011-01***Weight 51.7kg***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, En 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90***Manufactured in USA. THE RIO uses an infra-red camera for the purpose of spatial navigation. This camera is present on the Camera Stand and communicates with the Guidance Module to provide the locations of the tracked instruments (i.e. robotic-arm, patient trackers, probes, etc). The information is then used to provide the virtual representation of the patient anatomy and the tools on the monitor, and provides necessary information to the robotic-arm to ensure proper bone preparation.  Recall # Z-2232-2011
CODE
Lot #K081867
RECALLING FIRM/MANUFACTURER
MAKO SURGICAL COR., Ft. Lauderdale, FL, by letter on November 22, 2010. Firm initiated recall is ongoing.
REASON
This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. An electrical component of the camera was purchased from a non approved vendor.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
NY
_______________________________________
PRODUCT
Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2564-2011
CODE
Monaco Release 2.0.1 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated June 24, 2010. Firm initiated recall is ongoing.
REASON
Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans. One complaint was received.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Ref 8046M7. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Recall # Z-2221-2011
CODE
Lot 1024417, Use Before 2013-01
RECALLING FIRM/MANUFACTURER
Merz Aesthetics, Inc., Franksville, WI, via e-mail on April 6, 2011. Firm initiated recall is ongoing.
REASON
The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.
VOLUME OF PRODUCT IN COMMERCE
695 units
DISTRIBUTION
Taiwan
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Good Buddy Sun-Dried Rawhide For Dogs 10.5" Pressed Bone. Each bone individually shrink wrapped in clear plastic and labeled. Label reads in part: "GOOD BUDDY***SUN-DRIED RAWHIDE FOR DOGS***Net Wt. 270g***Made in Thailand. UPC: 7 80872 07003 4. Recall # V-112-2011
CODE
Lot #3189
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pet Appeal, Inc., Clackamas, OR, by telephone on December 28, 2010 and placards on December 29, 2010.
Manufacturer: Kuru Tannery Co., Ltd., Samut Prakan, Thailand. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9 bones
DISTRIBUTION
OR, UT
 
END OF ENFORCEMENT REPORT FOR JUNE 29, 2011
 
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