• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for July 28, 2010

July 28, 2010                                                                                        10-29

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Coarse ground black pepper packaged in clear, plastic bags sealed with a twist-tie. Recall # F-2523-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Binell Bros. Cutlery and Grinding, Dearborn, MI, by press release on March 30, 2010.
Manufacturing Firm: Mincing Trading Corporation, Dayton, NJ. FDA initiated recall is ongoing.
REASON
Black pepper has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
150 lbs
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Williams Ingredients B02602 Beef Gravy, Batch ID#WM19315105, packaged in 40-lb. paper bags. Recall # F-2524-2010;

2) Williams Ingredients B01695 MPK Stir Fry Seasoning, Batch ID#WM20014092, packaged in 50-lb. plastic lined boxes. Recall # F-2525-2010;

3) Williams Ingredients B02655 Veg Chicken Fat Flavor, Batch ID #WM19315106, packaged in 50-lb. plastic lined boxes. Recall # F-2526-2010;

4) Williams Ingredients B02683 Natural Meat Patty Seasoning, Batch ID #WM49315074, packaged in 50-lb. plastic lined boxes. Recall # F-2527-2010;

5) Williams Ingredients B00706 Meat Patty Seasoning (DLF #700520), Batch ID #WM29316118, packaged in 50-lb. plastic lined boxes. Recall # F-2528-2010;

6) Wind and Willow Toasted Garlic & Parmesan, Item 88501, 350/8.0-gram pouches. Recall # F-2529-2010;

7) Wind and Willow Toasted Garlic & Parmesan, Item 88502, 300/16.0-gram pouches. Recall # F-2530-2010;

8) Williams Spicy Wings Seasoned Coating Mix, packaged in 5-oz. Pouches. Recall # F-2531-2010;
 
9) La Tiara Taco Seasoning, packaged in 1-oz. pouches, 24/case. Recall # F-2532-2010;

10) Fajita Seasoning Mix, packaged in 1.25-oz. pouches, 24/case. Recall # F-2533-2010;

11) Amazing Taste Seasoning for Beef, packaged in 0.75-oz. pouches, 24/case. Recall # F-2534-2010;

12) Sun-Bird Thai Fried Rice, Riz Frit, Seasoning Mix/Melange d'assaisonnements, packaged in 28-g. pouches for Canadian distribution, 24/case. Recall # F-2535-2010:;

13) Sun-Bird Honey Sesame Chicken Seasoning Mix, packaged in 7/8-oz. pouches, 24/case. Recall # F-2536-2010;

14) Sun-Bird Lemon Chicken Stir-Fry, packaged in 3/4-oz. pouches, 24/case. Recall # F-2537-2010;

15) Sun-Bird Chop Suey Seasoning Mix, packaged in 1-oz. pouches, 24/case. Recall # F-2538-2010;

16) Sun-Bird Stir-Fry Seasoning Mix, packaged in 3/4-oz. pouches, 24/case. Recall # F-2539-2010;

17) Sun-Bird Chow Mein Seasoning Mix, packaged in 1-oz. pouches for U.S. distribution, and Sun-Bird Chow Mein, Nouilles Chinoises, Seasoning Mix/Melange pour assaisonnements, packaged in 28-g. pouches for Canadian Distribution, 24/case. Recall # F-2540-2010;

18) Beef Stew Seasoning Mix packaged in 1.5-oz. pouches, 24/case, under the following labels: (1) H-E-B Beef Stew Seasoning Mix, UPC 0 41220 10271 6, H-E-B, San Antonio, TX; and (2) Food Club Beef Stew Seasoning Mix, UPC 036800 30956 2. Recall # F-2541-2010;

19) Sun-Bird Fried Rice Seasoning Mix, packaged in 3/4-oz. pouches for U.S. distribution, and Sun-Bird Fried Rice, Riz Frit, Seasoning Mix/Melange d'assaisonnements, for Canadian distribution, packaged in 21-g. pouches, 24/case. Recall # F-2542-2010;

20) H-E-B Sloppy Joe Seasoning Mix, packaged in 1.25-oz. pouches, 24/case. Recall # F-2543-2010;

21) Pork Gravy Mix, packaged in 1-oz. pouches, 24/case, under the following labels: 1) Hy-Top Pork Gravy Mix, UPC 0 50700 55274 3; 2) Parade Pork Gravy Mix, UPC 0 50700 07284 5; 3) ShurFine Pork Gravy Mix, UPC 0 15400 86014 7; and 4) Western Family Pork Gravy Mix, UPC 0 15400 01198 3. Recall # F-2544-2010;

22) Tops Pork Gravy Mix, packaged in 1-oz. pouches, 24/case. Recall # F-2545-2010;

23) Chicken seasoning mix and cooking bag packaged under the following labels: 1) Best Yet Season 'n Bake Homestyle Chicken Cooking Bag & Seasoning Mix, packaged in 1 3/8-oz. pouches, 12/case, UPC 0 42187 41168 2; 2) Hy-Top Cooking Bag & Seasoning Blend for Chicken, packaged in 1.375-oz. pouches, 12/case, UPC 0 50700 04998 4; 3) ShurFine Season 'N Bake for Chicken with bag, packaged in 1.375-oz. pouches, 12/case, UPC 0 15400 86045 1; 4) Piggly Wiggly Season 'n Bake Roasting Bag and Seasoning, Chicken, packaged in 1 3/8-oz. pouches, 12/case, UPC 0 41290 41533 4; 5) Weis quality Chicken Season 'N Bake Roasting Bag and Seasoning, packaged in 1.37-oz. pouches, 12/case, UPC 0 41497 56850 5; 6) Shop 'n Save Chicken Roasting Bag & Seasoning Blend, packaged in 1 3/8-oz. pouches, 12/case, UPC 0 41130 35719 0; 7) Western Family Season 'n Bake for Chicken with Bag, packaged in 1.375-oz. pouches, 12/case, UPC 0 15400 01195 2. Recall # F-2546-2010;

24) Amazing Taste Seasoning for Burgers, packaged in 0.75-oz. pouches, 24/case. Recall # F-2547-2010;

25) Sun-Bird Hot & Spicy Szechwan Seasoning Mix, packaged in 3/4-oz. pouches, 24/case. Recall # F-2548-2010;

26) Hy-Top Marinade Southwest, Flavor for Meat or Chicken, packaged in 1.25-oz. pouches, 24/case. Recall # F-2549-2010;

27) H-E-B Meat Loaf Seasoning Mix, packaged in 1.5-oz. pouches, 24/case. Recall # F-2550-2010;

28) Amazing Taste Seasoning for Fajitas, packaged in 1-oz. pouches, 24/case. Recall # F-2551-2010;

29) Williams Spicy Wings Caribbean Jerk Seasoning, packaged in 2.5-oz. pouches, 2/6 packs/case (12 pouches). Recall # F-2552-2010;

30) Williams Country Store Home Style Soup Mix, Louisiana Style Gumbo, packaged in 8-oz. pouches, 6/case. Recall # F-2553-2010
CODE
1) Lot 9315;

2) Lot 0014;

3) Lot 9315;

4) Lot 9315;

5) Lots 0005, 0006, and 9316;

6) Lots 0005, 9313, and 9314;

7) Lots 0004, 0013, and 9317;

8) Lots W0004H, W0005H, and W0056H;

9) Lots W9324B, W0012F, and W0013F;

10) Carlita - Lots W9324G and W9365B; Parade - Lots W0014C; Hy-Top – Lots W9316C and W9317C;

11) Lots W00141, W93081, and W00131;

12) LotsW9309E and W0011G;

13) Lot W0007G;

14) Lot W0006G

15) Lots W9309G, W9310G, and W0006G;

16) Lot W9315G, W9316G, W9364E, W9365E, and W0014C;

17) Lot W9316G and W005G;

18) Lot H-E-B - W0005C; Food Club - W0021E and W9309C;

19) Lots W9317C, W9320G, W9324G, W9327G, W9334G, W9335G, W0004F, W0004G, W0018G, and W0019G;

20) Lot W0004C;

21) Hy-Top and Parade - Lots W0011Q; ShurFine and Western Family – Lot  W0011QJAN 11 12;

22) Lots W9327B and W9328B;

23) Best Yet - Lots W0006O; Hy-Top - Lots W0027P and W0028O; Shurfine - Lots W0034OFEB03 12; Piggly Wiggly - Lot W9338O; Weis - Lot W9343O; Shop 'n Save - Lot W9338O; Western Family - Lots W9343ODEC 09 11; and IGA - Lots W9338O and W0034O;

24) Lot W93161;

25) Lot W9322G;

26) Lot W9309C;

27) Lot W9320C;

28) Lot W93131;

29) Lot W9310F;

30) Lot W9317M
RECALLING FIRM/MANUFACTURER
Recalling Firm: CH Guenther & Sons, Inc., San Antonio, TX, by telephone, and letters on March 11, 2010.
Manufacturing Firm: Williams Foods, Lenexa, KS. FDA initiated recall is completed.
REASON
The products were manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 1,669,789 pouches
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT   
1) Kellogg's Apple Jacks, a) UPC 3800039136 1: 17 ounce package and b) UPC 3800039132 3: 8.7 ounce package. Recall # F-2567-2010;

2) Kellogg's Corn Pops, a) UPC 3800039109 5: 12.5 ounce package; UPC 3800039111 8: 17.2 ounce package; and UPC 3800039116 3: 9.2 ounce package. Recall # F-2568-2010;

3) Kellogg's Froot Loops, UPC 3800039118 7: 12.2 ounce package and UPC 3800039120 0: 17 ounce package. Recall # F-2569-2010;

4) Kellogg's Honey Smacks, UPC 3800039103 3: 15.3 ounce package. Recall # F-2570-2010
CODE
1) a) Better If Used Before Date APR 10 2011 and JUN 22 2011 KN;  b) Better If Used Before Date JUN 03 2011 and JUN 22 2011 Only products with the letters "KN" following the Better If Used By Date are included in the recall;
2) a) Better If Used Before Date MAR 26 2011 and JUN 22 2011 Only products with the letters "KN" following the Better If Used By Date are included in the recall. b) Better If Used Before Date APR 05 2011 and JUN 22 2011 Only products with the letters "KN" following the Better If Used By Date are included in the recall.
3) Both UPCs - Better If Used Before Date MAR 26 2011 and JUN 22 2011 Only products with the letters "KN" following the Better If Used By Date are included in the recall.

4) Better If Used Before Date MAR 26 2011 and JUN 22 2011 Only products with the letters "KN" following the Better If Used By Date are included in the recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg's Morning Foods, Battle Creek, MI, by press release on June 25, 2010.
Manufacturing Firm: Kellogg Company, Omaha NE. Firm initiated recall is ongoing.
REASON
Illnesses are associated with consumption of cereal that has an off-taste.
VOLUME OF PRODUCT IN COMMERCE
NONE
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
APOTEX CORP. Carbamazepine Tablets USP 200 mg 100 Tablets Rx Only, NDC 60505-0183-0. Batch JD2135. Recall # D-700-2010
CODE
Batch JD2135
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL, by letter and e-mail beginning April 15, 2010.
Manufacturer: Apotex Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.
REASON
Product was manufactured with an API batch that was Out Of Specification (OOS) for an unknown impurity.
VOLUME OF PRODUCT IN COMMERCE
19,389 bottles
DISTRIBUTION
NH, NJ, KY, IL, TX, CA, CT, PA, SC, FL, OH, WI, AZ, LA, CO

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-0954-10
CODE
Units: 0540694599; 0540680948; 0540677294; 0540675308
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Louisville, KY, by letter dated October 8, 2009.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland, IL
___________________________________
PRODUCT
1) Platelets, Recall # B-1430-10;
2) Red Blood Cells. Recall # B-1431-10
CODE
1) Unit: 3878524;
2) Unit: 3900206
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on September 23, 2009, September 28, 2009, October 7, 2009 and October 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1432-10;
2) Recovered Plasma. Recall # B-1433-10
CODE
1) and 2) Units: X73159; X48910
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on September 15, 2009, September 29, 2009 and September 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN, GA, Korea
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-1436-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1437-10
CODE
1) and 2) Unit: 041FT06668
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by fax on September 23, 2009. 
Manufacturer: American Red Cross Blood Services, Alabama Region, Huntsville, AL. 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
AL
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1713-10;
2) Red Blood Cells. Recall # B-1714-10;
3) Fresh Frozen Plasma. Recall # B-1715-10
CODE
1) Units: 53FH53811; 53FH51111; 53FH38995;
2) Units: 53FH51111; 53FH53811; 53FH34443; 53FH37002; 53FH38995; 53FH41019;
3) Unit: 53FH37002
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated February 12, 2005. 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
10 units
DISTRIBUTION
DC, MD, NC

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1716-10
CODE
Unit: LV24186
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on January 24, 2007.
Manufacturer: BloodCenter of Wisconsin, Inc., Kenosha, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Source Plasma. Recall # B-1719-10
CODE
Units: 0530610953, 530610212, 530609324, 530608415, 530607274, 530606678, 530605139, 530604848, 530603447, 530601759, 530601471, 5306000046, 530598857
RECALLING FIRM/MANUFACTURER
CSL Plasma, Lexington, KY, by electronic notification on August 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
IL, Germany, Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1720-10;
2) Recovered Plasma. Recall # B-1721-10
CODE
1) and 2) Unit: GP53048
RECALLING FIRM/MANUFACTURER
Blood Bank Of San Bernardino and Riverside Counties, San Bernardino, CA, by letter and email on February 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1731-10
CODE
Units: W012708002803; W012708001705
RECALLING FIRM/MANUFACTURER
Department of Army William Beaumont Army Medical Center, El Paso, TX, by letters dated September 22, 2009 and February 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1735-10
CODE
Units:  W249709900392; W249709900392
RECALLING FIRM/MANUFACTURER
Cumberland County Hospital System, Inc., Fayetteville, NC, by telephone and fax on January 28, 2010. 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
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1740-10
CODE
Units: 4080311265, 4080307585, 4080301710, 4080298495, 4080291465, 4080285663
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Akron, OH, by letter on August 8, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1753-10
CODE
Units: 4040077035, 4040076573, 4040076194, 4040075561, 4040075216, 4040072719, 4040072149, 4040071765, 4040070992, 4040070670, 4040069884, 4040069565, 4040068705, 4040068453, 4040059946, 4040059253, 4040058935, 4040058228, 4040057972, 4040057002, 4040056668, 4040055976, 4040055494, 4040054847, 4040054435, 4040053761, 4040053395, 4040052721, 4040052346, 4040051743, 4040051485, 4040050883, 4040050387, 4040049902, 4040049389, 4040049028, 4040048469, 4040048166, 4040047293, 4040046766, 4040046463, 4040045606, 4040045192, 4040044769, 4040044273, 4040043743, 4040043226, 4040042685, 4040042349, 4040041877, 4040041569, 4040041117, 4040040805
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL, by e-mail on February 6, 2007.
Manufacturer: ZLB Bioplasma Inc., Lexington, KY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
IL, Switzerland, Germany
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1769-10
CODE
Unit: P87454
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by electronic notification on April 9, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-1771-10
CODE
Unit: YZ029044
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank, Inc. of Wisconsin, Memphis, TN, by facsimile on June 14, 2007. 
Manufacturer: Interstate Blood Bank, Inc. of Wisconsin, Milwaukee, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1797-10
CODE
Unit: 72N290984
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by fax on April 2, 2010. Firm initiated recall is complete.
REASON
Blood product, with an absolute red cell volume below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-1798-10
CODE
Units: 4020446964, 4020445016, 4020444151, 4020442085, 4020434766, 4020430201, 4020423504, 4020421900
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Akron, OH, by letter and e-mail on January 7, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IL, Switzerland
____________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1799-10
CODE
Unit: 72L152973
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL, by fax on February 15, 2010. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-1800-10
CODE
Units: 4100303755, 4100302732, 4100300513
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Kansas City, MO, by letter on January 14, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL
____________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1801-10
CODE
Unit: 72L690370
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL, by fax on February 15, 2010. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
____________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1802-10
CODE
Unit: 72M851118
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc. – Birmingham Region, Birmingham, AL, by fax on March 8, 2010. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1804-10;
2) Fresh Frozen Plasma. Recall # B-1805-10
CODE
1) and 2) Unit: 49GV35518
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by fax on February 11, 2010 and March 16, 2010. 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
TX, OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1815-10
CODE
Unit: 72N068482
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 3, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1816-10
CODE
Unit: 72N492730
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 26, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1817-10
CODE
Unit: 55S55641
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by facsimile on March 26, 2010 and March 27, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL, AR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1820-10
CODE
Units: W224308500657, 662268, W224310510603, W224309503401
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by fax on March 15, 2010.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1821-10
CODE
Unit: 6204408
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on October 15, 2008. 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
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1833-10
CODE
Unit: W036509031626
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by e-mail on February 18, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-1835-10
CODE
Unit: W037910110761
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on March 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Source Plasma. Recall # B-1837-10
CODE
Unit: LC0635830
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by fax on December 9, 2009 and e-mail on April 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation information regarding a body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-1838-10;
2) Red Blood Cells. Recall # B-1839-10;
3) Fresh Frozen Plasma. Recall # B-1840-10
CODE
1) Units: W038509801565; W038508331750;
2) Units: W038509801565; W038508331750; 4133133;
3) Unit: 4133133
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on October 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
GA, SC
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1841-10;
2) Red Blood Cells. Recall # B-1842-10;
3) Plasma. Recall # B-1843-10
CODE
1) Unit: 4132630;
2) and 3) Units: W038508340256, 4132630
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on March 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Korea, Republic OF (South); GA
___________________________________
PRODUCT
Apheresis Platelets Irradiated Leukocytes Reduced-7D. Recall # B-1862-10
CODE
Unit: 4759300 (2 Units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by telephone on June 25, 2007. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1865-10
CODE
Unit: W043210019652 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on March 18, 2010. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN, GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1867-10;
2) Recovered Plasma. Recall # B-1868-10
CODE
1) and 2) Unit: W118809203823
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., St Augustine, FL, by fax and e-mail on March 12, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1869-10
CODE
Unit: 09EINA1862
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Elkhart, IN, by fax on April 5, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1870-10
CODE
Units: 0490718560, 0490721730, 0490720322
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prairie, TX, by e-mail on April 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

___________________________________
PRODUCT
Source Plasma. Recall # B-1871-10
CODE
Units: 6140261957, 6140259890
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Evansville, IN, by letter on February 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1873-10
CODE
W051510031497 (2 units)
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 9, 2010. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, NY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1707-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1708-10
CODE
1) Units: LJ61398, KL19674, FS17402;
2) Units: KF40804 (part 1), KF40804 (part 3)
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on December 13, 2006. Firm initiated recall is complete.
REASON
Blood products, for which storage conditions and shipment information were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1779-10;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1780-10
CODE
1) and 2) Unit: 9868176
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with gram positive rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1803-10
CODE
Unit: W045010012021
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on March 22, 2010 and by follow-up letter on March 30, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1811-10
CODE
Unit: KF67456
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on January 31, 2008.
Manufacturer: BloodCenter of Wisconsin, Inc., Waukesha, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received the shingles vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1812-10
CODE
Unit: W044608203256
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on February 22, 2008. Firm initiated recall is complete.
REASON
Blood product, manufactured without the additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1818-10
CODE
Unit: 55S55641
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by facsimile on March 26, 2010 and March 27, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL, AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1819-10
CODE
Unit: W041608052498U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS, by electronic notification on March 21, 2010.
Manufacturer: Blood Systems Inc/dba United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. Recall # Z-1781-2010;

2) ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. Recall # Z-1782-2010
CODE
Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871
RECALLING FIRM/MANUFACTURER
Defibtech LLC, Seymour, CT, by letter dated May 20, 2010. Firm initiated recall is ongoing.
REASON
The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy.
VOLUME OF PRODUCT IN COMMERCE
5,418 units
DISTRIBUTION
Nationwide, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland
___________________________________
PRODUCT
1) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1874-2010;

2) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1875-2010;

3) Navilyst Medical, Inc., Vaxcel (TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1876-2010;

4) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1877-2010;

5) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1878-2010;

6) Navilyst Medical, Inc., Vaxcel(TM) Port w PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1879-2010;

7) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology. --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1880-2010;

8) Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Recall # Z-1881-2010;

9) Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Recall # Z-1882-2010;

10) Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Recall # Z-1883-2010;

11) Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Recall # Z-1884-2010;

12) Navilyst Medical, Inc. Vaxcel (TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Ecall Z-1885-2010;

13) Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-340, UPN Product No. M001453400, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawals of venous blood samples. Recall # Z-1886-2010;

14) Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation. Indicated for use in patients who require long-term access to the central venous system for administration of fluids, including but not limited to, hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Recall # Z-1887-2010
CODE
1) Lots 1192327, 1194228, 1198103, 1199717, 1200699, 1203533, 1214352, 1214648, 1215656, 1219022, 1225627, 1228411, 1232462, 1235617, 1239039, 1240898, 1244262, 1246155, 1251020, 1252584, 1258101, 1259057, 1263710, 1266809, 1267689, 1271309, 1273698, 1276597, 1280329, 1285143, 1286832, 1290363, 1292668, 1294048, 1295863, 1297670, 1299166, 1300520, 1303564, 1307354, 1307625, 1308513, 1313095, 1316267, 1343197, 1346939, 1354063, 1360019, 1364758, 1365528, 1369511, 1373470, 1377611, 4001730, 4006506, 4014211;

2) Lots 1193952, 1194229, 1194579, 1198421, 1199718, 1202167, 1203534, 1208682, 1209895, 1210594, 1214353, 1214354, 1214649, 1215000, 1216849, 1218388, 1219023, 1219914, 1220172, 1220871, 1225940, 1226999, 1228412, 1229800, 1230457, 1230716, 1232463, 1233532, 1235319, 1236547, 1239040, 1239320, 1240035, 1242309, 1244263, 1245541, 1247037, 1248431, 1253940, 1257022, 1258102, 1259516, 1263711, 1264323, 1265770, 1267690, 1268134, 1272662, 1274410, 1276420, 1278339, 1281570, 1282582, 1285144, 1287097, 1288648, 1292158, 1294049, 1295864, 1298107, 1300117, 1304146, 1307355, 1309261, 1310503, 1313467, 1316807, 1319163, 1323431, 1325747, 1330396, 1333308, 1336009, 1340118, 1343198, 1346938, 1347894, 1351419, 1354064, 1355339, 1359540, 1361868, 1364432, 1366291, 1368296, 1369512, 1371077, 1372172, 1372901, 1373965, 1374540, 1375756, 1377315, 4000285, 4001731, 4003056, 4006508, 4007735, 4014212, 4014213;

3) Lots 1193953, 1195311, 1198104, 1200700, 1202457, 1204614, 1207340, 1207664, 1214355, 1214650, 1215657, 1216850, 1221191, 1227000, 1228413, 1231143, 1232464, 1235320, 1239041, 1239321, 1240899, 1244264, 1247038, 1248432, 1250527, 1252585, 1257023, 1258103, 1263712, 1265771, 1267691, 1273901, 1277633, 1281030, 1285145, 1288649, 1294480, 1295865, 1296141, 1296709, 1297923, 1300521, 1307356, 1307357, 1307358, 1311034, 1313096, 1313097, 1348374, 1353274, 1355601, 1356197, 1365529, 1367037, 1368843, 1370103, 1372521, 1374541, 1377316, 1377612, 1377844, 1378093, 1378345, 1380085, 1381887, 4000284, 4001732, 4007724, 4014661;

4) Lots 1192332, 1198106, 1202172, 1204956, 1206895, 1208684, 1214359, 1214651, 1219666, 1227904, 1230056, 1231144, 1233993, 1239665, 1243253, 1245545, 1248436, 1251234, 1252586, 1257028, 1258107, 1262111, 1265536, 1267698, 1268135, 1275216, 1278343, 1286359, 1288651, 1292866, 1295866, 1305978, 1308308, 1314993, 1321214, 1329618, 1341521, 1349623, 1351954, 1357024, 1359288, 1362390, 1363949, 1365530, 1371855, 1373199, 1374542, 1377845, 1379701, 4001736, 4007727, 4010947, 1282267D;

5) Lots 1193957, 1198107, 1198423, 1199454, 1200701, 1206362, 1214360, 1224333, 1228418, 1229803, 1239044, 1240037, 1243254, 1250135, 1252587, 1257029, 1258424, 1266810, 1267699, 1277308, 1278344, 1285147, 1285594, 1289476, 1296998, 1299862, 1307903, 1311285, 1316268, 1334583, 1351212, 1354065, 1355341, 1365531, 1367038, 1370574, 4007741;

6) Lots 1193958, 1198108, 1204957, 1214361, 1216851, 1223413, 1225631, 1227631, 1228419, 1229804, 1231145, 1232870, 1233994, 1235321, 1239045, 1239666, 1243255, 1247040, 1250136, 1257030, 1260760, 1263716, 1267700, 1271896, 1278345, 1278799, 1281754, 1285148, 1290364, 1294050, 1297426, 1305979, 1307359, 1308767, 1311690, 1318214, 1327177, 1332149, 1336928, 1341264, 1344773, 1347895, 1353759, 1356587, 1359289, 1362391, 1363950, 1366735, 1372174, 1373686, 1376248, 1380992, 4001737, 4010940, 4014270;

7) Lots 1192334, 1192739, 1198109, 1201031, 1214652, 1216852, 1219667, 1229805, 1232871, 1235618, 1239046, 1239323, 1244265, 1248437, 1252588, 1257031, 1258108, 1261021, 1265537, 1265995, 1267701, 1270135, 1275503, 1276599, 1277634, 1281571, 1285149, 1285401, 1290026, 1290639, 1292159, 1294051, 1294762, 1295867, 1296142, 1302934, 1305980, 1307360, 1334584, 1364172, 4000283;

8) Lots 1267692, 1283242, 1284566, 1290025, 1296410, 1300524, 1306963, 1312590, 1320987, 1327651, 1344772, 1359287, 1366292, 1370777, 1377613, 4001733;

9) Lots 1263713, 1267693, 1283243, 1287605, 1292865, 1299860, 1302380, 1309262, 1310743, 1319164, 1323675, 1357022, 1372173;
 
10) Lots 1263714, 1264775, 1267694, 1269714, 1272320, 1273699, 1275502, 1276598, 1283244, 1284100, 1285146, 1285400, 1286080, 1287098, 1288650, 1292669, 1294481, 1295072, 1297671, 1299594, 1301292, 1310032, 1312322, 1316808, 1321707, 1345647, 1346950, 1354323, 1355340, 1359541, 1360401, 1364170, 1367275, 1373685, 1381270, 4001734;

11) Lots 1264324, 1277462, 1288305, 1294761, 1304148, 1320497, 1356811;

12) Lots 1264960, 1283246, 1342235, 1371638;

13) Lots 1263715, 1277463, 1294482, 1332871;

14) Lots 1267697, 1290638, 1317254, 1342462, 1362918
RECALLING FIRM/MANUFACTURER
Recalling Firm: Navilyst Medical, Inc., Glens Falls, NY, by letters on May 13, 2010, May 14, 2010 and June 3, 2010.
Manufacturers: Navilyst Medical, Inc., Glens Falls, NY; Multi-Med, Inc., Homestead Mills Complex, Keene, NH. Firm initiated recall is ongoing.
REASON
FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
VOLUME OF PRODUCT IN COMMERCE
54,809 units (43,227 Nationwide & 11,582 Internationally)
DISTRIBUTION
Nationwide and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom

___________________________________
PRODUCT
1) 22ga x 1" Straight Huber Needle, Model number 10600218. This product is a small gauge needle intended for single use hypodermic access to implanted ports. Recall # Z-1888-2010;

2) 22ga x 1" Right Angle Huber Needle, Model number 10600219. This product is a small gauge needle intended for single use hypodermic access to implanted ports. Recall # Z-1889-2010
CODE
1) Lot Number 9B020M;
2) Lot Number 9B017M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Multi-Med, Inc., West Swanzey, NH, by letter dated May 26, 2010.
Manufacturer: Multi-Med, Inc., Keene, NH. Firm initiated recall is ongoing.
REASON
FDA sample determined the needles to be coring.
VOLUME OF PRODUCT IN COMMERCE
10,169 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. Product codes: a) GXMRSA/SA-BC-10 and b) GXMRSA/SA-BC-CE-10. Recall # Z-1898-2010
CODE
a) Lot numbers 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302;

b) Lot numbers 01001, 01101, 01301
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letter on April 5, 2010 and April 9, 2010. Firm initiated recall is ongoing.
REASON
The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
VOLUME OF PRODUCT IN COMMERCE
5,510
DISTRIBUTION
Nationwide and countries of Europe, Taiwan, and Australia
___________________________________
PRODUCT
1) Constellation Vision System, Model: Constellation Vision System w/Laser, Catalogue Number: 8065751145 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1924-2010;

2) Constellation Vision System, Model: Constellation Vision System w/o Laser, Catalogue Number: 8065751147 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1925-2010;

3) Constellation Vision System, Model: Constellation Tabletop, Catalogue Number: 8065751150 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1926-2010;

4) Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1927-2010;

5) Constellation Vision System, Model: Constellation LT, Catalogue Number: 8065751549 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1928-2010;

6) Constellation Vision System, Model: Constellation LXT, Catalogue Number: 8065751550 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1929-2010;

7) Constellation Vision System, Model: Constellation LX, Catalogue Number: 8065751551 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1930-2010;

8) Constellation Vision System, Model: Constellation B, Catalogue Number: 8065751552 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1931-201;

9) Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1932-2010;

10) Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1933-2010;

11) Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558. The Constellation Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. Recall # Z-1934-2010
CODE
All lot/serial numbers
RECALLING FIRM/MANUFACTURER
Alcon Research LTD dba Alcon Laboratories, Inc., Irvine, CA, by letter dated July 2, 2010. Firm initiated recall is ongoing. 
REASON
The recall was initiated after Alcon identified both system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System.
VOLUME OF PRODUCT IN COMMERCE
824 units
DISTRIBUTION
Nationwide and International

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
1) Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile; Part # 10-1500-021. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0339-2010;

2) Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile; Part # 10-1500-022. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-034-2010;

3) Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile; Part # 10-1500-023. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0341-2010;

4) Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile; Part # 10-1500-024. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0342-2010;

5) Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile; Part # 10-1500-025. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0343-2010;

6) Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile; Part # 10-1500-026. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0344-2010;

7) Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile; Part # 10-1500-031. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0345-2010;

8) Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile; Part # 10-1500-032. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0346-2010;

9) Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile; Part # 10-1500-033. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0347-2010;

10) Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile; Part # 10-1500-034. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0348-2010;

11) Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile; Part # 10-1500-035. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0349-2010;

12) Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile; Part # 10-1500-036. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0350-2010;

13) Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile; Part # 10-1500-037. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0351-2010;

14) Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile; Part # 10-1500-071. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0352-2010;

15) Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile; Part # 10-1500-072. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0353-2010;

16) Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile; Part # 10-1500-073. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0354-2010;

17) Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile; Part # 10-1500-074. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0355-2010;

18) Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile; Part # 10-1500-075. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0356-2010;

19) Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile; Part # 10-1500-076. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0357-2010;

20) Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile; Part # 10-1500-081. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0358-2010;

21) Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile; Part # 10-1500-082. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0359-2010;

22) Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile; Part # 10-1500-083. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0360-2010;

23) Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile; Part # 10-1500-084. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0361-2010;

24) Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile; Part # 10-1500-085. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0362-2010;

25) Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile; Part # 10-1500-086. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0363-2010;

26) Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile; Part # 10-1500-087. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity. Recall # Z-0364-2010
CODE
1) Lots 105397 and 105398;
2) Lots 105402 and 105403;
3) Lots 105413 and 105414;
4) Lots 105417 and 105418;
5) Lots 105423 and 105424;
6) Lots 105428 and 105429;
7) Lots 105464 and 105465;
8) Lots 105468 and 105469;
9) Lots 105472 and 105473;
10) Lots 105477 and 105478;
11) Lots 105481 and 105482;
12) Lots 105485 and 105486;
13) Lots 105489 and 105490;
14) Lots 105400 and 105401;
15) Lots 105407 and 105408;
16) Lots 105415 and 105416;
17) Lots 105419 and 105420;
18) Lots 105425 and 105426;
19) Lots 105430 and 105431;
20) Lots 105466 and 105467;
21) Lots 105470 and 105471;
22) Lots 105474 and 105475;
23) Lots 105479 and 105480;
24) Lots 105483 and 105484;
25) Lots 105487 and 105488;
26) Lots 105491 and 105492
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orthopediatrics Corp., Warsaw, IN, by email dated July 28, 2009.
Manufacturers: Orthopediatrics Corp., Warsaw, IN; C & A Tool Engineering Inc., Churubusco, IN. Firm initiated recall is ongoing.
REASON
The potential exists for the nails to fracture during insertion of the nail.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) DigitalDiagnost General radiographic examinations and applications wherever a solid state X-ray imaging device can be used. 2.x systems. Recall # Z-0847-2010;

2) BuckyDiagnost General Radiography and Tomography examination of patients in supine, seated, or standing positions. Recall # Z-0848-2010;

3) EasyDiagnost Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations. Recall # Z-0849-2010
CODE
1) FC071200040;
2) FC070400034;
3) FC070600046
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters, dated January 20 & 21, 2010. Firm initiated recall is complete.
REASON
Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G. Recall # Z-0856-2010
CODE
 DxI software versions: 4.2 and 4.2.1.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter dated October 28, 2009. Firm initiated recall is ongoing.
REASON
This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and stopping sample processing, the system will post a yellow caution event and continue to operate with the dispense plate in an elevated position until the instrument is reinitialized. Potentially affected results are not flagged.
VOLUME OF PRODUCT IN COMMERCE
377 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166. The reagents are for in vitro diagnostic use on a BD FACSCount instrument. Recall # Z-1007-2010
CODE
Lot Number: 89031721
RECALLING FIRM/MANUFACTURER
BD Biosciences, Systems & Reagents, San Jose, CA, by letters on January 29, 2009. Firm initiated recall is complete.
REASON
The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
WA, MO, NV, CA, NY, PA, AL, and OR
 ___________________________________
PRODUCT
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. a) 115 stacks and 65 stacks; Intended to display mammographic images. Recall # Z-1799-2010
CODE
a) Lot Number: 36810031 and b) Lot Number: 36750062
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated April 22, 2010.
Manufacturer: Agfa Materials Corp., Goose Creek, SC. Firm initiated recall is ongoing.
REASON
The RF tags on the white protection sheets of the media stacks were incorrect.
VOLUME OF PRODUCT IN COMMERCE
180 boxes
DISTRIBUTION
AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA, WV, British Columbia and Guatemala
___________________________________
PRODUCT
Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials. Recall # Z-2025-2010
CODE
Lot 9126057, Exp May 04, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by fax and e-mail on May 19, 2010.
Manufacturer: Becton Dickinson, Grayson, GA. Firm initiated recall is ongoing.
REASON
In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
VOLUME OF PRODUCT IN COMMERCE
93 units
DISTRIBUTION
Nationwide, Belgium and Korea

END OF ENFORCEMENT REPORT FOR JULY 28, 2010

#