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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 22, 2011

 

June 22, 2011                                                                                        11-25
 
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT
1) CLAIROL natural instincts Creme Shade 03G Light Golden Blonde (Honey Creme), UPC 3 81519 04528 8, Finished Product Code: 84838954. Recall # F-1393-2011;
 
2) CLAIROL natural instincts vibrant Shade 6A Light Cool Brown (Wake-up Cocoa), UPC 3 81519 05004 6, Finished Product Code: 84839162. Recall # F-1394-2011;
 
3) CLAIROL natural instincts Creme Shade 7.5 Dark Blonde (Maple Creme), UPC 3 81519 04529 5, Finished Product Code: 84838961. Recall # F-1395-2011;
 
4) CLAIROL natural instincts vibrant Shade 9 Light Blonde (Blonde Vibrance), UPC 3 81519 04999 6, Finished Product Code: 84839150. Recall # F-1396-2011;
 
5) CLAIROL natural instincts vibrant Shade 10 Extra Light Blonde (Sun-Kissed Blonde), UPC 3 81519 04998 9, Finished Product Code: 84839146. Recall # F-1397-2011;
 
6) CLAIROL natural instincts Shade 11G Lightest Golden Brown (Amber Shimmer), UPC 3 81519 00292 2, Finished Product Code: 84839010. Recall # F-1398-2011;
 
7) CLAIROL natural instincts Shade 16 Light Auburn (Spiced Tea), UPC 3 81519 00300 4, Finished Product Code: 84839098. Recall # F-1399-2011;
 
8) CLAIROL natural instincts Creme Shade 21G Medium Golden Brown (Caramel Creme), UPC 3 81519 04637 7, Finished Product Code, 84839000. Recall # F-1400-201l;
 
9) CLAIROL natural instincts Creme Shade 23R Medium Auburn (Raspberry Creme), UPC 3 81519 04532 5, Finished Product Code: 84838979. Recall # F-1401-2011;
 
10) CLAIROL natural instincts Creme Shade 30R Dark Auburn (Cherry Creme), UPC 3 81519 04533 2, Finished Product Code: 84838987. Recall # F-1402-2011;
 
11) CLAIROL natural instincts Creme Shade 31 Darkest Brown (Coffee Creme), UPC 3 81519 04531 8, Finished Product Code: 84838970. Recall # F-1403-2011;
 
12) CLAIROL natural instincts Shade 35 Brown Black (Ebony Mocha), UPC 3 81519 03235 6, Finished Product Code: 84839117. Recall #F-1404-2011
CODE
1) Lot Codes: 0277030200, 0325030200, 0326030200, 0326030201 & 0356030200;
 
2) Lot Codes: 0293030200, 0309030200, 0309030201, 0310030200, 1005030200, 1005030201, 1007030200, 1007030201, 1007030202, 1039030200, 1063030200 & 1063030201;
 
3) Lot Codes: 0277030200, 0341030200, 0342030200 & 0355030200;
 
4) Lot Codes: 0299030200, 0299030201, 0300030200, 0300030201, 0316030200, 0316030201, 0320030200, 1040030200 & 1066030200;
 
5) Lot Codes: 0279030200, 0287030200, 0287030201, 0308030200I, 0308030201, 0309030200, 0322030200, 0322030201, 0323030200, 0323030201, 1017030200, 1018030200, 1018030201, 1041030200, 1060030200 & 1061030200;
 
6) Lot Codes: 0326030200, 0356030200, 0356030201, 1019030200, 1049030200, 1059030200, 1077030200 & 1077030201;
 
7) Lot Codes: 0327030200, 1018030200l, 1050030200l, & 1078030200;
 
8) Lot Codes: 0326030200, 0326030201, 0326030202, 0327030200, 0347030200, 0356030200, 1076030200 & 1077030200;
 
9) Lot Codes: 0324030200, 0324030201, 0324030202, 0355030200, 0356030200, 0356030201, 0356030202 & 1076030200;
 
10) Lot Codes: 0324030200, 0324030201, 0324030202, 1010030200 & 047030200;
 
11) Lot Codes: 0285030200, 0298030200, 0320030200, 0321030200, 343030200, 0347030200, 1008030200, 1046030200, 1047030200, 1052030200, 1052030201, 1076030200;
 
12) Lot Codes: 0348030200, 0349030200, 0349030201 & 1078030200
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble, Cincinnati, OH, by press release on April 7, 2011 and by press release and letters on April 15, 2011.  
Manufacturer: Procter & Gamble.De Mexico S.A De C.V, Me, Mexico. Firm initiated recall is ongoing.
REASON
Twelve(12) Shades of Clairol Natural Instincts hair color contains the wrong ColorFresh!TM Revitalizer in product kits.
VOLUME OF PRODUCT IN COMMERCE
851, 618 units
DISTRIBUTION
Nationwide, Canada, Jamaica, Puerto Rico & Trinadad
___________________________________
PRODUCT
BRATZ MAKE UP DESIGN SKETCH BOOK, UPC: 0-35051-50478-8, MGA Item # 504788. Recall # F-1405-2011
CODE
DATE CODE: 45210BVE 53210BVE 47210BVE 02211BVE 49210BVE 08211BVE 51210BVE 09211BVE 45510BVE 12211BVE BATCH CODES BV6897 BV6997 BV7040
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mga Entertainment, Inc., Van Nuys, CA,
Manufacturer: Beauty Vision Ltd., Shenzhen, China. Firm initiated recall is ongoing.
REASON
The recall was initiated due to potential contamination of the products with certain microorganisms, namely Staphylococcus warneri and Staphylococcus intermedius.
VOLUME OF PRODUCT IN COMMERCE
19,680 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) J. Gumbos brand Red Beans, refrigerated product packed and distributed in . cardboard shipping cases, Net weight 48 lbs. The product is packed 6 x 8 lb. boxes per case. The product labeling reads: J. Gumbo's Red Beans Batch: RB-7105 Expiration Date: 6/18/11 Refrigerated 4/29/2012 Frozen Keep Refrigerated or Frozen Reheat to 165 F. to 175 F. before consumption. Recall # F-1390-2011;
 
2) J. Gumbos brand Etoufee, refrigerated product packed and distributed in cardboard shipping cases, Net weight 48 lbs. The product is packed 6 x 8 lb. boxes per case. The product labeling reads: J. Gumbo's Etouffee Batch: ET-0164 Expiration Date: 7/1/11 Refrigerated 5/2/2012 Frozen Keep Refrigerated or Frozen Reheat to 165 F. to 175 F. before consumption. Recall # F-1391-2011
CODE
1) Expiration Date: 6/18/11 Refrigerated 4/29/2012;
2) Expiration Date: 7/1/11 Refrigerated 5/2/2012 Frozen
RECALLING FIRM/MANUFACTURER
Stir the Pot LLC (dba J Gumbos Commissary), Louisville, KY, by telephone, and E-mail beginning May 5, 2011, and by press release on May 6, 2011. FDA Initiatedrecall is ongoing.
REASON
Products were distributed with labeling which failed to include a warning statement for the allergen ingredients: Soy, and Fish.
VOLUME OF PRODUCT IN COMMERCE
1) 20.5 cases; 2) 37.66 cases
DISTRIBUTION
KY, OH, GA, IN
___________________________________
PRODUCT
DR. SNACK brand CHOCO.RAISIN, 12.00 oz, UPC 80555493026. The product is packaged in a clear hard plastic (clam-shell) container. The product is labeled for each individual retail customer. Recall # F-1392-2011
CODE
Sell By 03/05/2012
RECALLING FIRM/MANUFACTURER
B.C.S. International Corp., Long Island City, NY, by press release on May 24, 2011 and by hand delivered letters beginning May 26, 2011. FDA initiated recall is ongoing.
REASON
Containers of the affected Sell By date code of DR. SNACK brand CHOCO RAISIN may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
NY, NJ, PA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
El Sol de Mexico Chorizo Mix, 25 lbs; The product label reads in part: El Sol de Mexico *** CHORIZO MIX *** NET. WT. 25 LBS. Product is packaged in brown cardboard boxes with a label affixed to the side of the box. Packaging that comes into contact with product is a clear flexible plastic bag. Recall # F-1389-2011
CODE
No coding
RECALLING FIRM/MANUFACTURER
El Sol De Mexico Spice Company, Inc., Chula Vista, CA, by letter on February 28, 2011. Firm initiated recall is ongoing.
REASON
Product contains non-permitted colors - Ponceau 4R and Carmoisine. It also contains undeclared Sunset Yellow FCF, which is certifiable as FD&C Yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
351.5 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
The unsweetened applesauce in water is packed in 106 oz (or one gallon size) cans, 6 cans are packed in a cardboard case and sold under Snokist brand. The Snokist brand has a UPC 0 2090016047 5. The product is labeled in parts: "***SNOKIST***100% Washington State Apples***NATURAL applesauce IN WATER***NET WT. 106 OZ. (3.01kg)***INGREDIENTS: APPLES AND WATER***PACKED BY: SNOKIST GROWERS YAKIMA, WA 98907***PRODUCT OF U.S.A***". Recall # F-1406-2011
CODE
16047 P08KU, 16047 P08MA, 16047 P08MB, 16047 P08MC, 16047 P08RD, and 16047 P08LU. xx:xx: represents time of pack. Code interpretation of 16047: 1 = Apples; 6 = Water; 0 = Blend; 4 = Sauce; 7 = #10 size can (can dimension 603 x 700). Bottom Line Code Interpretation of P08KU: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); K = 19th (day of manufacture); U = Graveyard (shift period). Bottom Line Code interpretation of P08MA: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); M = 21st (day of manufacture); A = Day (shift period). Bottom Line Code interpretation for P08MB: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); M = 21st (day of manufacture); B = Day (shift period). Bottom Line Code interpretation for P08MC: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); M = 21st (day of manufacture); C = Day (shift period). Bottom Line Code interpretation for P08RD: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); R = 24th (day of manufacture); D = Day (shift period). Bottom Line Code interpretation for P08LU: P = Product Line for #10 Sauce; 0 = Crop year (2010); 8 = January (month of manufacture); L = 20th (day of manufacture); U = Graveyard (shift period)
RECALLING FIRM/MANUFACTURER
Snokist Growers, Yakima, WA, by telephone on May 9, 2011 and by letters on May 11, 2011, FDA initiated recall is ongoing.
REASON
Canned unsweetened applesauce in water was recalled due to the identification of cans with knocked down seam flanges, which may result in the lack of an effective seal causing spoilage and exterior damage from the leakage of product.
VOLUME OF PRODUCT IN COMMERCE
3310 Cases (6/106 oz. Cans per Case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
***FRESH CRAB MEAT***PRE COOKED***PROCESSED BY IMDACA***CONTENTS: 20 LBS***Distributed by BONAMAR***A Seafood Company***Retailed unit labeled in part: ***MAJESESTIC BAY***CLAW***PESO NETO 454g***PRE-COOKEDiii FRESHCRAB MEAT***PRODUCT MADE IN THE REPUBLIC BOLIVARIANA DE VENEZUELA***Procamar***" ACTUAL LABEL: "***CARNE DE CANGREJO PRECOCIDA CLAW MAJESTIC BAY CRAB MEAT CARNE DE CANGREJO***REG. SANT. A-84.053 CPE0410190463 PESO NETO 454g/16 OZ/1 LB/NET WEIGHT KEEP REFRIGERATED32 F/ MANTENER REFRIGERADO A O C***CRAB MEAT This crab meat was hand picked from The Callinectes Sapidus, the real Blue Crab***PRE-COOKED FRESH CRAB MEAT PRODUCT MADE IN THE REPUBLICA BOLIVARIANA DE VENEZUELA***PROCESADO Y EMPACADO: Procamar, Rif: J-30935741-5 Av 1 La Guajira, Sector La Guajira, La Canada de Urdaneta - Estado Zulia. Recall # F-1407-2011
CODE
Lot 4715
RECALLING FIRM/MANUFACTURER
Bonamar Corp., Miami, FL, by letter (fax) and telephone on May 27, 2011.
Manufacturer: Procesadora El Cangrejito Del Mar, La Canada De Urdaneta Edo, Venezuela. FDA initiated recall is ongoing.
REASON
Product tested positive for Chloramphenicol by FDA laboratory analysis.
VOLUME OF PRODUCT IN COMMERCE
1,208 lbs
DISTRIBUTION
PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Methyldopate HCL Injection, USP, 250 mg/5 mL (50 mg/mL), 5 mL single dose vial, packaged in 10 x 5 mL single dose vials per carton, Rx Only, NDC 0517-8905-10. Recall # D-573-2011
CODE
Lot 0152, Exp 03/12
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letters dated June 3, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Some vials contained translucent visual particles consistent with glass delamination.
VOLUME OF PRODUCT IN COMMERCE
58,420 vials
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Oxygen, Compressed USP UN 1072, Rx only, distributed under the company name of Olympic Pharmacy and Health Care. Product is packaged in aluminum cylinders, sizes E, M9, M6 and D in gaseous form, delivered to the patient via inhalation. Primary label with green and white background, yellow hazard diamond and black lettering reads in part:"***OXYGEN, COMPRESSED USP UN 1972***". Manufacturer information label with blue background and silver writing. This label is normally affixed inside the white rectangle found on the primary product label. Oxygen safety information label with white background, yellow hazard diamond and black writing. The label reads in part: "***Oxygen, Compressed, USP UN 1072***". Grocery type label with white background and black writing. An 8 digit lot code as described previously followed by Lot No and Expiration Date. The numbers following Expiration Date are actually the Serial Number for the gas cylinder. No Expiration Date is included on the product labeling. Recall # D-575-2011
CODE
Lot codes: 06011001, 06031001, 06221001, 07021001, 07091001, 07121001, 07231001, 07271001, 07281001, 08041001, 08121001, 08191001, 08231001, 08251001, 08261001, 09021001, 09081001, 09141001, 09161001, 09281001, 10111001, 10131001, 10191001, 11021001, 11041001, 11101001, 11131001, 11161001, 11241001, 11261001, 11301001; 12031001, 12071001, 12131001, 12231001, 12241001, 12311001, 01051101, 01101101, 01111101, 01181101, 01211101, 01281101, 02071101, 02091101, 02161101, 02241101, and 03011101. The lot number is an 8-digit number and is broken down as follows: The first and second digits represent the month; The third and fourth digits represent the day; The fifth and sixth digits represent the year; The seventh and eighth digits represent the sequential fill for that date of manufacture. The numbers following Expiration Date are actually the Serial Number for the gas cylinder. No Expiration Date is included on the product labeling.
RECALLING FIRM/MANUFACTURER
Olympic Pharmacy & Healthcare, Gig Harbor, WA, by visit beginning on March 10, 2011 and letter dated April 25, 2011. FDA initiated recall is ongoing.
REASON
CGMP deviations: There is no identity or purity testing on incoming oxygen gas, and lack of documentation that calibration of Servomex gas analyzer was performed prior to conducting the post-fill purity test for each filling.
VOLUME OF PRODUCT IN COMMERCE
46 lots (total 808 cylinders of various sizes)
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Ropinirole Hydrochloride Tablets, 3 mg, 100 count in bottle, Rx only; NDC #64720-205-10. Recall # D-569-2011;
 
2) Ropinirole Hydrochloride Tablets, 4 mg, 100 count in bottle, Rx only; NDC #64720-206-10. Recall # D-570-2011;
 
3) Ropinirole Hydrochloride Tablets, 5 mg, 100 count in bottle, Rx only; NDC #64720-207-10. Recall # D-571-2011
CODE
1) Lot number: 101312, Exp date: 06/11; Lot number: 101279, Exp date: 06/11; Lot number: 101866, Exp date: 08/11; Lot number: 102465, Exp date: 10/11; Lot number: 102797, Exp date: 11/11; Lot number: 103538, Exp date: 01/12;
 
2) Lot number: 101863, Exp date: 08/11; Lot number: 102396, Exp date: 10/11; Lot number: 103255, Exp date: 12/11;
 
3) Lot number: 102799, Exp date: 11/11
RECALLING FIRM/MANUFACTURER
CorePharma, Middlesex, NJ, by letters dated March 30, 2011. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect (obsolete) version of the package outsert.
VOLUME OF PRODUCT IN COMMERCE
77,604 bottles; 100 tablets each
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lactulose Solution USP, 10 g/15 mL, 32 fl oz (946 mL) bottle, Rx only, NDC #0121-0577-32, UPC 3 0121-0577-32 1. Recall # D-574-2011
CODE
Lot 0H31, Exp 08 12
RECALLING FIRM/MANUFACTURER
Pharmaceutical Associates Inc., Greenville, SC, by letter dated April, 25, 2011. FDA initiated recall is ongoing.
REASON
CGMP Deviations: A deviation in the production process, specifically the packaging operation, could have compromised the integrity of the drug product.
VOLUME OF PRODUCT IN COMMERCE
12,192 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Methylprednisolone Tablets, USP, 4 mg, Rx only; 1) 100 count bottles, NDC: 59746-001-06; 2) 21 tablet unit dose blister pack, NDC: 51991-188-31 and NDC: 59746-001-03. Recall # D-576-2011;
 
2) Methylprednisolone Tablets, USP, 8 mg, 25 count bottles, Rx only, NDC: 59746-002-04. Recall # D-577-2011
CODE
1) Lot number: 9P128, Exp. date: 04/11; Lot number: 9P217, Exp. date: 04/11; Lot number: 9P368, Exp. date: 04/11; Lot number: 9P235, Exp. date: 05/11; Lot number: 9P274, Exp. date: 06/11; Lot number: 9P416, Exp. date: 07/11; Lot number: 9P421, Exp. date: 08/11; Lot number: 9P488, Exp. date: 08/11; Lot number: 9P623, Exp. date: 10/11; Lot number: 9P519, Exp. date: 10/11; Lot number: 9P585, Exp. date: 10/11; Lot number: 9P662 , Exp. date: 11//11; Lot number: OP080, Exp. date: 11/11; Lot number: OP025, Exp. date: 01/11; Lot number: 9P492, Exp. date: 01/11; Lot number: OP193, Exp. date: 03/11; Lot number: OP248, Exp. date: 04/11; Lot number: OP283, Exp. date: 05/11; Lot number: OP360, Exp. date: 06/11; Lot number: OP486, Exp. date: 07/11; Lot number: OP580, Exp. date: 09/11; Lot number: OP621, Exp. date: 09/11; Lot number: OP669, Exp. date: 11/11; Lot number: 1P002, Exp. date: 01/11; Lot number: 1P058, Exp. date: 02/11; Lot number: 1P084, Exp. date: 02/11; Lot number: 9P203, Exp. date: 03/11; Lot number: 9P195, Exp. date: 04/11; Lot number: 9P308, Exp. date: 06/11; Lot number: 9P351, Exp. date: 06/11; Lot number: 9P400, Exp. date: 07/11; Lot number: 9P443, Exp. date: 09/11; Lot number: 9P559, Exp. date: 11/11; Lot number: OP008, Exp. date: 01/12; Lot number: OP079, Exp. date: 02/12; Lot number: OP092, Exp. date: 03/12; Lot number: OP118, Exp. date: 03/12; Lot number: OP226, Exp. date: 04/12; Lot number: OP600, Exp. date: 10/12; NDC: 59746-001-03; Lot number: 9P134, Exp. date: 03/11; Lot number: 9P135, Exp. date: 03/11; Lot number: 9P136, Exp. date: 03/11; Lot number: 9P137, Exp. date: 03/11; Lot number: 9P138, Exp. date: 03/11; Lot number: 9P139, Exp. date: 03/11; Lot number: 9P140, Exp. date: 03/11; Lot number: 9P141, Exp. date: 03/11; Lot number: 9P142, Exp. date: 03/11; Lot number: 9P144, Exp. date: 03/11; Lot number: 9P179, Exp. date: 03/11; Lot number: 9P180, Exp. date: 03/11; Lot number: 9P181, Exp. date: 03/11; Lot number: 9P182, Exp. date: 04/11; Lot number: 9P183, Exp. date: 04/11; Lot number: 9P184, Exp. date: 04/11; Lot number: 9P185, Exp. date: 04/11; Lot number: 9P186, Exp. date: 04/11; Lot number: 9P187, Exp. date: 04/11; Lot number: 9P188, Exp. date: 04/11; Lot number: 9P189, Exp. date: 04/11; Lot number: 9P190, Exp. date: 04/11; Lot number: 9P191, Exp. date: 04/11; Lot number: 9P192, Exp. date: 04/11; Lot number: 9P193, Exp. date: 04/11; Lot number: 9P194, Exp. date: 04/11; Lot number: 9P196, Exp. date: 04/11; Lot number: 9P197, Exp. date: 05/11; Lot number: 9P248, Exp. date: 05/11; Lot number: 9P249, Exp. date: 05/11; Lot number: 9P250, Exp. date: 05/11; Lot number: 9P251, Exp. date: 05/11; Lot number: 9P252, Exp. date: 05/11; Lot number: 9P267, Exp. date: 05/11; Lot number: 9P268, Exp. date: 05/11; Lot number: 9P269, Exp. date: 05/11; Lot number: 9P270, Exp. date: 06/11; Lot number: 9P309, Exp. date: 06/11; Lot number: 9P310, Exp. date: 06/11; Lot number: 9P311, Exp. date: 06/11; Lot number: 9P312, Exp. date: 06/11; Lot number: 9P313, Exp. date: 06/11; Lot number: 9P314, Exp. date: 06/11; Lot number: 9P315, Exp. date: 06/11; Lot number: 9P316, Exp. date: 06/11; Lot number: 9P346, Exp. date: 06/11; Lot number: 9P347, Exp. date: 06/11; Lot number: 9P348, Exp. date: 06/11; Lot number: 9P349, Exp. date: 06/11; Lot number: 9P350, Exp. date: 06/11; Lot number: 9P352, Exp. date: 06/11; Lot number: 9P399, Exp. date: 07/11; Lot number: 9P395, Exp. date: 07/11; Lot number: 9P396, Exp. date: 07/11; Lot number: 9P397, Exp. date: 07/11; Lot number: 9P398, Exp. date: 07/11; Lot number: 9P401, Exp. date: 07/11; Lot number: 9P403, Exp. date: 07/11; Lot number: 9P452, Exp. date: 08/11; Lot number: 9P402, Exp. date: 08/11; Lot number: 9P404, Exp. date: 08/11; Lot number: 9P429, Exp. date: 08/11; Lot number: 9P430, Exp. date: 08/11; Lot number: 9P431, Exp. date: 08/11; Lot number: 9P432, Exp. date: 08/11; Lot number: 9P433, Exp. date: 08/11; Lot number: 9P434, Exp. date: 08/11; Lot number: 9P435, Exp. date: 08/11; Lot number: 9P453, Exp. date: 09/11; Lot number: 9P436, Exp. date: 09/11; Lot number: 9P437, Exp. date: 09/11; Lot number: 9P438, Exp. date: 09/11; Lot number: 9P449, Exp. date: 09/11; Lot number: 9P450, Exp. date: 09/11; Lot number: 9P451, Exp. date: 09/11; Lot number: 9P476, Exp. date: 09/11; Lot number: 9P477, Exp. date: 09/11; Lot number: 9P493, Exp. date: 09/11; Lot number: 9P494, Exp. date: 09/11; Lot number: 9P556, Exp. date: 10/11; Lot number: 9P495, Exp. date: 10/11; Lot number: 9P496, Exp. date: 10/11; Lot number: 9P497, Exp. date: 10/11; Lot number: 9P498, Exp. date: 10/11; Lot number: 9P499, Exp. date: 10/11; Lot number: 9P500, Exp. date: 10/11; Lot number: 9P501, Exp. date: 10/11; Lot number: 9P502, Exp. date: 10/11; Lot number: 9P526, Exp. date: 10/11; Lot number: 9P527, Exp. date: 10/11; Lot number: 9P528, Exp. date: 10/11; Lot number: 9P549, Exp. date: 10/11; Lot number: 9P550, Exp. date: 10/11; Lot number: 9P551, Exp. date: 10/11; Lot number: 9P552, Exp. date: 10/11; Lot number: 9P553 , Exp. date: 10/11; Lot number: 9P554, Exp. date: 10/11; Lot number: 9P647, Exp. date: 11/11; Lot number: 9P593, Exp. date: 11/11; Lot number: 9P600, Exp. date: 11/11; Lot number: 9P555, Exp. date: 11/11; Lot number: 9P557, Exp. date: 11/11; Lot number: 9P558, Exp. date: 11/11; Lot number: 9P576, Exp. date: 11/11; Lot number: 9P594, Exp. date: 11/11; Lot number: 9P595, Exp. date: 11/11; Lot number: 9P596, Exp. date: 11/11; Lot number: 9P597, Exp. date: 11/11; Lot number: 9P598, Exp. date: 11/11; Lot number: 9P599, Exp. date: 11/11; Lot number: 9P601, Exp. date: 11/11; Lot number: 9P602, Exp. date: 11/11; Lot number: 9P631, Exp. date: 11/11; Lot number: 9P632, Exp. date: 11/11; Lot number: 9P633, Exp. date: 11/11; Lot number: 9P634, Exp. date: 11/11; Lot number: 9P635, Exp. date: 11/11; Lot number: 9P698, Exp. date: 12/11; Lot number: 9P701, Exp. date: 12/11; Lot number: 9P643, Exp. date: 12/11; Lot number: 9P644, Exp. date: 12/11; Lot number: 9P645, Exp. date: 12/11; Lot number: 9P646, Exp. date: 12/11; Lot number: 9P648, Exp. date: 12/11; Lot number: 9P699, Exp. date: 12/11; Lot number: 9P700, Exp. date: 12/11; Lot number: OP004, Exp. date: 01/12; Lot number: OP005, Exp. date: 01/12; Lot number: OP006, Exp. date: 01/12; Lot number: OP007, Exp. date: 01/12; Lot number: OP009, Exp. date: 01/12; Lot number: OP010, Exp. date: 01/12; Lot number: OPOll, Exp. date: 01/12; Lot number: OP012, Exp. date: 01/12; Lot number: OP013, Exp. date: 01/12; Lot number: OP014, Exp. date: 01/12; Lot number: OP015, Exp. date: 01/12; Lot number: OP055, Exp. date: 01/12; Lot number: OP056, Exp. date: 01/12; Lot number: OP057, Exp. date: 01/12; Lot number: OP058, Exp. date: 01/12; Lot number: 9P702, Exp. date: 01/12; Lot number: 9P703, Exp. date: 01/12; Lot number: OP106, Exp. date: 02/12; Lot number: OP107, Exp. date: 02/12; Lot number: OP108, Exp. date: 02/12; Lot number: OP059, Exp. date: 02/12; Lot number: OP060, Exp. date: 02/12; Lot number: OP062, Exp. date: 02/12 ; Lot number: OP063, Exp. date: 02/12; Lot number: OP064, Exp. date: 02/12; Lot number: OP065, Exp. date: 02/12; Lot number: OP066, Exp. date: 02/12; Lot number: OP067, Exp. date: 02/12; Lot number: OP161, Exp. date: 03/12; Lot number: OP10l, Exp. date: 03/12; Lot number: OP102, Exp. date: 03/12; Lot number: OP103, Exp. date: 03/12; Lot number: OP104, Exp. date: 03/12; Lot number: OP105, Exp. date: 03/12; Lot number: OP109, Exp. date: 03/12; Lot number: OPll0, Exp. date: 03/12; Lot number: OP114, Exp. date: 03/12; Lot number: OP115, Exp. date: 03/12; Lot number: OP116, Exp. date: 03/12; Lot number: OPl17, Exp. date: 03/12; Lot number: OP151, Exp. date: 03/12; Lot number: OP152, Exp. date: 03/12; Lot number: OP153, Exp. date: 03/12; Lot number: OP217, Exp. date: 04/12; Lot number: OP218, Exp. date: 04/12; Lot number: OP219, Exp. date: 04/12; Lot number: OP220, Exp. date: 04/12; Lot number: OP154, Exp. date: 04/12; Lot number: OP155, Exp. date: 04/12; Lot number: OP156, Exp. date: 04/12; Lot number: OP157, Exp. date: 04/12; Lot number: OP158, Exp. date: 04/12; Lot number: OP159, Exp. date: 04/12; Lot number: OP160, Exp. date: 04/12; Lot number: OP162, Exp. date: 04/12; Lot number: OP163, Exp. date: 04/12; Lot number: OP164, Exp. date: 04/12; Lot number: OP165, Exp. date: 04/12; Lot number: OP211, Exp. date: 04/12; Lot number: OP212, Exp. date: 04/12; Lot number: OP213, Exp. date: 04/12; Lot number: OP214, Exp. date: 04/12; Lot number: OP215, Exp. date: 05/12; Lot number: OP216, Exp. date: 05/12; Lot number: OP221, Exp. date: 05/12; Lot number: OP222, Exp. date: 05/12; Lot number: OP223, Exp. date: 05/12; Lot number: OP224, Exp. date: 05/12; Lot number: OP225, Exp. date: 05/12; Lot number: OP318, Exp. date: 05/12; Lot number: OP319, Exp. date: 05/12; Lot number: OP320, Exp. date: 05/12; Lot number: OP321, Exp. date: 05/12; Lot number: OP322, Exp. date: 06/12; Lot number: OP323, Exp. date: 06/12; Lot number: OP324, Exp. date: 06/12; Lot number: OP325, Exp. date: 06/12; Lot number: OP326, Exp. date: 06/12; Lot number: OP327, Exp. date: 06/12; Lot number: OP328, Exp. date: 06/12; Lot number: OP329, Exp. date: 06/12; Lot number: OP330, Exp. date: 06/12; Lot number: OP331, Exp. date: 06/12; Lot number: OP332, Exp. date: 06/12; Lot number: OP377, Exp. date: 06/12; Lot number: OP378, Exp. date: 06/12; Lot number: OP379, Exp. date: 06/12; Lot number: OP380, Exp. date: 06/12; Lot number: OP466, Exp. date: 07/12; Lot number: OP381, Exp. date: 07/12; Lot number: OP382, Exp. date: 07/12; Lot number: OP383, Exp. date: 07/12; Lot number: OP384, Exp. date: 07/12; Lot number: OP385, Exp. date: 07/12; Lot number: OP386, Exp. date: 07/12; Lot number: OP387, Exp. date: 07/12; Lot number: OP388, Exp. date: 07/12; Lot number: OP389, Exp. date: 07/12; Lot number: OP390, Exp. date: 07/12; Lot number: OP391, Exp. date: 07/12; Lot number: OP454, Exp. date: 07/12; Lot number: OP453, Exp. date: 08/12; Lot number: OP455, Exp. date: 08/12; Lot number: OP456, Exp. date: 08/12; Lot number: OP457, Exp. date: 08/12; Lot number: OP462, Exp. date: 08/12; Lot number: OP463, Exp. date: 08/12; Lot number: OP464, Exp. date: 08/12; Lot number: OP465, Exp. date: 08/12; Lot number: OP467, Exp. date: 08/12; Lot number: OP468, Exp. date: 09/12; Lot number: OP469, Exp. date: 09/12; Lot number: OP470, Exp. date: 09/12; Lot number: OP471, Exp. date: 09/12; Lot number: OP524, Exp. date: 09/12; Lot number: OP525, Exp. date: 09/12; Lot number: OP526, Exp. date: 09/12; Lot number: OP527, Exp. date: 09/12; Lot number: OP528, Exp. date: 09/12; Lot number: OP529, Exp. date: 09/12; Lot number: OP532, Exp. date: 09/12; Lot number: OP533, Exp. date: 09/12; Lot number: OP534, Exp. date: 09/12; Lot number: OP540, Exp. date: 10/12; Lot number: OP541, Exp. date: 10/12; Lot number: OP542, Exp. date: 10/12; Lot number: OP543, Exp. date: 10/12; Lot number: OP598, Exp. date: 10/12; Lot number: OP599, Exp. date: 10/12; Lot number: OP601, Exp. date: 10/12; Lot number: OP602, Exp. date: 10/12; Lot number: OP603, Exp. date: 10/12; Lot number: OP604, Exp. date: 10/12; Lot number: OP606, Exp. date: 10/12; Lot number: OP605, Exp. date: 11/12; Lot number: OP607, Exp. date: 11/12; Lot number: OP608, Exp. date: 11/12; Lot number: OP609, Exp. date: 11/12; Lot number: OP610, Exp. date: 11/12; Lot number: OP612, Exp. date: 11/12; Lot number: OP677, Exp. date: 11/12; Lot number: OP678, Exp. date: 11/12; Lot number: OP679, Exp. date: 11/12; Lot number: OP680, Exp. date: 11/12; Lot number: OP681, Exp. date: 11/12; Lot number: OP682, Exp. date: 11/12; Lot number: OP683, Exp. date: 12/12; Lot number: OP684, Exp. date: 12/12; Lot number: OP685, Exp. date: 12/12; Lot number: OP686, Exp. date: 12/12; Lot number: OP687, Exp. date: 12/12; Lot number: OP688, Exp. date: 12/12; Lot number: OP689, Exp. date: 12/12; Lot number: OP690, Exp. date: 12/12; Lot number: OP691, Exp. date: 12/12; Lot number: OP727, Exp. date: 12/12; Lot number: OP728, Exp. date: 12/12; Lot number: OP729, Exp. date: 12/12; Lot number: OP730, Exp. date: 12/12; Lot number: OP731, Exp. date: 12/12; Lot number: OP732, Exp. date: 12/12; Lot number: OP733, Exp. date: 01/13; Lot number: OP734, Exp. date: 01/13; Lot number: OP735, Exp. date: 01/13; Lot number: OP736, Exp. date: 01/13; Lot number: OP737, Exp. date: 01/13; Lot number: OP738, Exp. date: 01/13; Lot number: OP739, Exp. date: 01/13; Lot number: OP740, Exp. date: 01/13; Lot number: OP741, Exp. date: 01/13; Lot number: 1P023, Exp. date: 01/13; Lot number: 1P024, Exp. date: 01/13; Lot number: 1P025, Exp. date: 01/13; Lot number: 1P100, Exp. date: 02/13; Lot number: 1P026, Exp. date: 02/13; Lot number: 1P027, Exp. date: 02/13; Lot number: 1P028, Exp. date: 02/13; Lot number: 1P029, Exp. date: 02/13; Lot number: 1P030, Exp. date: 02/13; Lot number: 1P031, Exp. date: 02/13; Lot number: 1P032, Exp. date: 02/13; Lot number: 1P033, Exp. date: 02/13; Lot number: 1P034, Exp. date: 02/13; Lot number: 1P035, Exp. date: 02/13; Lot number: 1P036, Exp. date: 02/13; Lot number: 1P094, Exp. date: 02/13; Lot number: 1P095, Exp. date: 02/13; Lot number: 1P096, Exp. date: 02/13; Lot number: 1P097, Exp. date: 02/13; Lot number: 1P098, Exp. date: 02/13; Lot number: 1P099, Exp. date: 02/13; Lot number: 1P101, Exp. date: 02/13; Lot number: 1P102, Exp. date: 02/13; Lot number: lP103, Exp. date: 02/13;
 
2) Lot number: 9P444, Exp. date: 0811; Lot number: 9P655, Exp. date: 09/11; Lot number: 9P680, Exp. date: 09/11; Lot number: OP085, Exp. date: 09/11; Lot number: OP194, Exp. date: 03/11; Lot number: OP268, Exp. date: 04/11; Lot number: OP442, Exp. date: 07/11; Lot number: OP539, Exp. date: 07/11; Lot number: OP58, Exp. date: 07/11; Lot number: OP719, Exp. date: 11/11; Lot number: lP059, Exp. date: 11/11
RECALLING FIRM/MANUFACTURER
Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD, by letter on March 23/2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient Drug): Products may contain soft (partially eroded or low weight) tablets.
VOLUME OF PRODUCT IN COMMERCE
15,032,615 units
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
Promotional material - Color Chart Magnet 801194 - Normal Color Range of Sulfite-Free Amino Acid Solutions; Reference number 801194. Recall # D-578-2011
CODE
5K 3/10
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Deerfield, IL, by letters dated March 3, 2011. FDA initiated recall is ongoing.
REASON
Misbranded - Promotion literature contains unapproved theoretical claims.
VOLUME OF PRODUCT IN COMMERCE
1,091 magnets
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1399-11
CODE
Unit: KR92235
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile on June 18, 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
CA
___________________________________
PRODUCT
Plasma. Recall # B-1431-11
CODE
Unit: W116111001960
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital & University Health Center, Sioux Falls, SD, by telephone on March 31, 2011. Firm initiated recall is complete.
REASON
Blood product, with an unresolved anti-HIV testing result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1452-11
CODE
Unit: 8247726
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on July 5, 2005. 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
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1456-11
CODE
Unit: LR0461527
RECALLING FIRM/MANUFACTURER
DCI Biologicals Little Rock, LLC, Little Rock AK, by fax on March 17, 2011 and E-mail on May 9, 2011. Firm initiated recall is complete.
REASON
Blood product, not quarantined after post donation information was received regarding a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
___________________________________
PRODUCT
Flow-Set Fluorospheres, Part Numbers: 6607007. Recall # B-1474-11
CODE
Lot number: 7524013F
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter beginning on April 26, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Beckman Coulter's Flow-Set Fluorospheres, with some incorrect Target Values for stemOne and stemCXP, were distributed.
VOLUME OF PRODUCT IN COMMERCE
440 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1475-11
CODE
Units: GF40635 and GF40640
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile and telephone on March 15, 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
NJ, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1491-11
CODE
Unit #’s: LE89217, LE99518, LE99529, LE99530, LE99551, LG05775, LG05776, LG05777, LG05779, LG05781, LG05784, LG05785
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 28, 2005 and facsimile February 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA, FL, NY
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1494-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1495-11
CODE:
1 Unit: 8207799;
2) Units: 8003703; 8207799; 82100654; 8214224; 8219445; 8227947; 8505960; 8507478
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on August 11, 2006. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA and Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced . Recall # B-1497-11;
2) Platelets Leukocytes Reduced. Recall # B-1498-11
CODE
1) and 2) Unit: 17FR50755
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by email and letter on July 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN, PA, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1504-11
CODE
Units: W087610544086; W087610533021
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by e-mail on April 5, 2011. 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
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-1509-11
CODE
Unit: W040711320658
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on March 21, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1510-11
CODE
Unit: W050911019424
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by telephone on April 13, 2011 and by letter dated April 16, 2011. Firm initiated recall is complete.
REASON
Blood product, for which the quality control testing was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Source Plasma. Recall # B-1511-11
CODE
Units: 2010289209, 2010288945, 2010288405, 2010288140, 2010287553, 2010287092, 2010286654, 2010286189, 2010285446, 2010292213, 2010290141, 2010289831
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc. Indianapolis, IN, by facsimile on February 22, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1512-11
CODE
Unit: W037911556209 (2 units)
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on April 27, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1513-11
CODE
Unit: W087611000035
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc, Richmond, VA, by e-mail on May 5, 2011. 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
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1515-11
CODE
Unit: W037711120821
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated April 19, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested for White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1546-11
CODE
Unit: 42FM62344
RECALLING FIRM/MANUFACTURER
American National Red Cross, Cleveland, OH, by telephone on May 3, 2011. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1589-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1590-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1591-11
CODE
1) and 3) Unit: W036810204642;
2) Unit: W036810817414
RECALLING FIRM/MANUFACTURER
Community Blood Centers/S Florida, Inc, Lauderhill, FL, by telephone on April 15, 2011 and by letter dated April 18, 2011. 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
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1592-11
CODE
Units: W036511020045, W036510076989, W036509168720
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on May 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a dura mater graft, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, LA
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1595-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1596-11
CODE
1) Unit: W165711003099W;
2) Units: W165711003618I, W165711007697Z, W165711008667V
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital Inc., Attn Blood Bank, Baton Rouge, LA, by telephone and facsimile on May 24, 2011.Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Rejuvenated Deglycerolized Irradiated. Recall # B-1400-11
CODE
Unit: 2595210
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on April 9, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1476-11
CODE
Units:0490287633, 0490287916, 0490288924, 0490289233, 0490290036, 0490290162, 0490291495, 0490291699, 0490292229, 0490293188, 0490293592, 0490294082, 0490294750, 0490295080, 0490295752, 0490296301, 0490296788, 0490297388, 0490299231, 0490299707, 0490301141, 0490301423, 0490302660, 0490303045, 0490304229, 0490304584, 0490305425, 0490306154, 0490306231, 0490307096, 0490310756, 0490311069, 0490311624, 0490312180, 0490314157, 0490314492, 0490315323, 0490316110, 0490316286, 0490317113, 0490317600, 0490318041, 0490318550, 0490318991, 0490320178, 0490320678, 0490321066, 0490321734, 0490322011, 0490323288, 0490324005, 0490324422, 0490325240, 0490325999, 0490326397, 0490327055, 0490327524, 0490328235, 0490328524, 0490329232, 0490329599, 0490330510, 0490330777, 0490331387, 0490331861, 0490332822, 0490333156, 0490333548, 0490334016, 0490334344, 0490334857, 0490335270, 0490335924, 0490336428, 0490337221, 0490337560, 0490338438, 0490338696, 0490339283, 0490339525, 0490339989, 0490340797, 0490341570, 0490342462, 0490342721, 0490343345, 0490343657, 0490344309, 0490344801, 0490345285, 0490346011, 0490346484, 0490347092, 0490347541, 0490348323, 0490348743, 0490349763, 0490350363, 0490350721, 0490351388, 0490351723, 0490352304, 0490352669, 0490353314, 0490353675, 0490355282, 0490355566, 0490356387, 0490357045, 0490357883, 0490358249, 0490359004, 0490359425, 0490360043, 0490360622, 0490361271, 0490361921, 0490362424, 0490363329, 0490363864, 0490364273, 0490366123, 0490366630, 0490367622, 0490368067, 0490370035, 0490370559, 0490371122, 0490371752, 0490372293, 0490373678, 0490374377, 0490374849, 0490375572, 0490376007, 0490376602, 0490377124, 0490377816, 0490378253, 0490378982, 0490379423, 0490380258, 0490380638, 0490381397, 0490382000, 0490382341, 0490383147, 0490383587, 0490385352, 0490387411, 0490387793, 0490388460, 0490388870, 0490389819, 0490390316, 0490390874, 0490391636, 0490391980, 0490392554, 0490393843, 0490394478, 0490394766, 0490395451, 0490395898, 0490396608, 0490397003, 0490397682, 0490398446, 0490398800, 0490399506, 0490401162, 0490404867, 0490406116, 0490406575, 0490407359, 0490407817, 0490408240, 0490408829, 0490409434, 0490409780, 0490410384, 0490410821, 0490411563, 0490411930, 0490412539, 0490439670, 0490439832, 0490440472, 0490441564, 0490442248, 0490442479, 0490442977, 0490443279, 0490443743, 0490444007, 0490444531, 0490444754, 0490445272, 0490445653, 0490446017, 0490446400, 0490446761, 0490447181, 0490447541, 0490447996, 0490448386, 0490455849, 0490477453, 0490478584, 0490478995, 0490483875, 0490484235, 0490485004, 0490485287, 0490486006, 0490486425, 0490487074, 0490487417, 0490488223, 0490488548, 0490489231, 0490489615, 0490490315, 0490490770, 0490491402, 0490492008, 0490492463, 0490492931, 0490493462, 0490494086, 0490494410, 0490494913, 0490495194, 0490504288, 0490504902, 0490340882, 0490364822, 0490384374, 0490393572, 0490399885, 0490448786, 0490449359, 0490449870, 0490450440, 0490450796, 0490451497, 0490452320, 0490456523, 0490458154, 0490459081, 0490460268, 0490477827, 0490479724, 0490480082, 0490480728, 0490481155, 0490481838, 0490482216, 0490482967, and 0490483275
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, by facsimile on February 9, 2010.
Manufacturer: CSL Plasma, Inc. Grand Prairie, TX, Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
260 units
DISTRIBUTION
NC, IL, and Marburg Germany
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1499-11
CODE
Unit: 17FR50755
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by email and letter on July 11, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN, PA, IL
___________________________________
PRODUCT
1) Fresh Frozen Plasma (Apheresis). Recall # B-1502-11;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1503-11
CODE
1) Unit: W045011902804;
2) Units: W045011004042 (2 units), W045011902804, W045011900351
RECALLING FIRM/MANUFACTURER
 by telephone on March 2, 2011 and by letters dated March 29, 2011 and March 31, 2011. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as to total volume or anticoagulant volume, were distributed.
VOL UME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MO, KS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1514-11
CODE
Unit: W037911109855
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by facsimile on May 20, 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
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1517-11
CODE
Unit: 19LJ61621
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, electronic notification on April 13, 2011. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1548-11
CODE
Unit: W045011046095
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater KC, Kansas City, MO, by facsimile on May 3, 2011. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of plasma and anticoagulant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1593-11
CODE
Unit: W038110106292
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL, by letter dated April 4, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1594-11
CODE
Unit W333611030593
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg Bld Center, Davenport, IA, by telephone and facsimile on April 20, 2011. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the JkA red cell antibody, but was labeled as negative for anti-JkA, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) Synchron LX20, Part Number: 466200. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Recall # Z-2130-2011;
 
2) Synchron LX20 PRO, Part Number: 476100. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Recall # Z-2131-2011;
 
3) Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Recall # Z-2132-2011
CODE
All Serial Numbers.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter on April 5, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.
VOLUME OF PRODUCT IN COMMERCE
1,284 units total for all products
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Churchill Medical Systems AMS-7080CP (Dressing Change Kit). The device intended use is a dressing change kit. Recall # Z-2388-2011; 
 
2) Churchill Medical Systems AMS-8316CP-1 (Central Line Dressing Kit). The device intended use is a central line dressing kit. Recall # Z-2389-2011;
 
3) Churchill Medical Systems AMS-8431CP (PICC insertion Tray). The device intended use is a PICC insertion tray. Recall # Z-2390-2011;
 
4) Churchill Medical Systems: 1) AMS-9189CP-1 (Dressing Change Kit) -Medium Glove. Churchill Medical Systems: 2) AMS-9189CP (Dressing Change Kit)-Large Glove. The devices intended use is a Dressing Change Kit. Recall # Z-2391-2011
CODE
1) Lot Numbers: 10J29, 10J55, 11A18, 11A47 and 11B06;
2) Lot Numbers: 10I60, 10K42 and 10F87;
3) Lot Number: 10H30;
4) 1) Lot Numbers: 1006150, 1006149 and 1008143; 2) Lot Number: 1003527
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vygon Corp., Montgomeryville, PA, by letter dated April 20, 2011 and May 31, 2011.
Manufacturer: Churchill Medical Systems, Inc., Dover, NH, Firm initiated recall is ongoing.
REASON
Product recalled due to potential bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
20,200 units
DISTRIBUTION
FL, MA, MD, and VA
___________________________________
PRODUCT
1) Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. Recall #Z-2419-2011;
 
2) Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation.  This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. Recall # Z-2418-2011
CODE
1) All lots;
 
2) All lots are impacted. 13478001, 13479862, 13483687, 13483794, 13486679, 13488281, 13492691, 13495381, 13495537, 13501702, 13509959, 13510363, 13510388, 13510970, 13513269, 13513370, 13518405, 13522499, 13525880, 13526246, 13529890, 13532559, 13532599, 13534080, 13537206, 13537450, 13541221, 13542989, 13543371, 13543372, 13543373, 13543374, 13543903, 13544086, 13548035, 13550071, 13551639, 13555107, 13557249, 13558528, 13560226, 13561192, 13561925, 13565449, 13572049, 13575534, 13576371, 13582549, 13587068, 13589401, 13591521, 13595076, 13598770, 13602027, 13604910, 13605911, 13607907, 13612369, 13613621, 13616694, 13617441, 13620814, 13623271, 13625428, 13627096, 13627610, 13628377, 13628378, 13628480, 13642454, 13644574, 13645440, 13648480, 13649064, 13649555, 13651806, 13659069, 13660352, 13663881, 13666991, 13670858, 13671958, 13675335, 13677173, 13679538, 13681808, 13685028, 13692281, 13711461, 13717161, 13721872, 13726417, 13729970, 13733692, 13736433, 13738543, 13744275, 13748118, 13751320, 13753544, 13755722, 13763259, 13766230, 13770525, 13772349, 13774311, 13779785, 13790510, 13795482, 13796520, 13799042, 13803863, 13807009, 13807405, 13810319, 13811040, 13813370, 13817138, 13823987, 13827155, 13828363, 13830503, 13834945, 13837411, 13846140, 13862022, 13866829, 13867763, 13867812, 13869465, 13871530, 13874961, 13874989, 13878848, 13881217, 13881902, 13883719, 13886293, 13889336, 13889690, 13892663, 13893369, 13897082, 13900781, 13906150, 13908756, 13909098, 13909550, 13909967, 13912695, 13913663, 13915857, 13916951, 13916953, 13920105, 13920710, 13920803, 13920805, 13921106, 13923537, 13924672, 13927066, 13928293, 13930289, 13932251, 13932695, 13935416, 13935514, 13936063, 13938497, 13938680, 13940859, 13943943, 13947364, 13950149, 13960559, 13964584, 13967316, 13970980, 13977845, 13982090, 13987794, 13990244, 13994171, 13997365, 14001705, 14006979, 14023919, 14032268, 14036676, 14038052, 14043294, 14048150, 14052253, 14054270, 14057246, 14059185, 14060218, 14060730, 14063990, 14064764, 14068345, 14071841, 14075967, 14075968, 14080311, 14081712, 14083655, 14086847, 14090453, 14090833, 14094058, 14098066, 14099289, 14101324, 14102725, 14105453, 14106322, 14109716, 14109807, 14113183, 14117941, 14125549, 14137883, 14140518, 14144461, 14147692, 14154145, 14156848, 14162309, 14164380, 14165091, 14167666, 14179509, 14183540, 14186298, 14191171, 14194753, 14198644, 14202609, 14203395, 14206342, 14206443, 14209358, 14210282, 14217182, 14219362, 14219394, 14226258, 14230360, 14235075, 14238057, 14239219, 14253978, 14255111, 14256086, 14256852, 14257870, 14258124, 14258292, 14260466, 14262256, 14267351, 14272686, 14272726, 14274123, 14275822, 14276666, 14278698, 14279887, 14280587, 14283635, 14285242, 14287832, 14289523
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letters dated March 14, 2011.
Manufacturer: Boston Scientific Corp., Fremont, CA. Firm initiated recall is ongoing.
REASON
Boston Scientific is initiating a Customer Notification involving the Atlantis SR Pro 2 Catheter. Boston Scientific has determined that there has been a recent increase in the number of complaints with the Atlantis SR Pro2 (Approval number: 21200BZY00484000) for catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement in the United States and Puerto Rico. Any recalled product in customer's inventory should be segregated and returned to Boston Scientific. Boston Scientific will provide Atlantis SR Pro Coronary Imaging Catheters as replacements
VOLUME OF PRODUCT IN COMMERCE
96,702 units
DISTRIBUTION
Nationwide, PR, Japan, Trinidad, Tobago, and American Virgin Islands
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw. Recall # Z-2102-2011;
 
2) Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw. Recall # Z-2103-2011
CODE
1) Lot Code: HLPB4G;
2) Lot Code: HLPB4F
RECALLING FIRM/MANUFACTURER
DePuy Spine, Inc., Raynham, MA, by letter dated March 22, 2011. Firm initiated recall is ongoing.
REASON
Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide and Canada, Australia, Belgium, France, Hungary, Italy, Malaysia, Slovenia, UK, South Africa, Switzerland, and UAE
___________________________________
PRODUCT
ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Recall # Z-2112-2011
CODE
All production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc, by letters on February 4, and on February 24th, 2011.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
The firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the cassette, this could lead to a clinically serious misinterpretation of the results and possible misdiagnosis and/or mal-therapy in the critical patient care setting.
VOLUME OF PRODUCT IN COMMERCE
533 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2176-2011
CODE
Units: HZ10003 HZ10151 HZ10305 HZ10507 HZ10670 HZ11015 HZ12040 HZ12090 HZ13050 HZ17041 HZ18062 HZ10008 HZ10153 HZ10311 HZ10508 HZ10674 HZ11016 HZ12041 HZ12091 HZ13052 HZ17042 HZ18066 HZ10013 HZ10154 HZ10313 HZ10509 HZ10675 HZ11017 HZ12042 HZ12092 HZ13053 HZ17043 HZ18068 HZ10014 HZ10155 HZ10316 HZ10513 HZ10676 HZ11018 HZ12043 HZ12093 HZ13054 HZ17044 HZ18069 HZ10015 HZ10157 HZ10326 HZ10528 HZ10679 HZ11019 HZ12044 HZ12094 HZ13055 HZ17046 HZ18070 HZ10017 HZ10159 HZ10330 HZ10534 HZ10681 HZ11020 HZ12045 HZ12095 HZ13056 HZ17048 HZ18076 HZ10019 HZ10165 HZ10333 HZ10537 HZ10684 HZ11021 HZ12046 HZ12096 HZ13057 HZ17049 HZ18077 HZ10023 HZ10170 HZ10335 HZ10540 HZ10685 HZ11022 HZ12047 HZ12097 HZ13058 HZ17051 HZ18079 HZ10024 HZ10172 HZ10337 HZ10541 HZ10689 HZ11023 HZ12048 HZ12098 HZ13059 HZ17057 HZ18085 HZ10025 HZ10179 HZ10343 HZ10542 HZ10693 HZ11024 HZ12049 HZ12099 HZ13060 HZ17058 HZ18088 HZ10026 HZ10181 HZ10347 HZ10544 HZ10698 HZ11025 HZ12050 HZ12100 HZ13062 HZ17059 HZ18118 HZ10027 HZ10182 HZ10352 HZ10545 HZ10700 HZ12001 HZ12051 HZ12101 HZ13063 HZ17061 HZ18120 HZ10029 HZ10183 HZ10357 HZ10547 HZ10703 HZ12002 HZ12052 HZ12102 HZ13064 HZ17062 HZ18126 HZ10044 HZ10185 HZ10368 HZ10552 HZ10706 HZ12003 HZ12054 HZ12103 HZ15006 HZ17065 HZ18131 HZ10046 HZ10187 HZ10372 HZ10553 HZ10712 HZ12004 HZ12056 HZ12104 HZ15070 HZ17067 HZ18132 HZ10048 HZ10188 HZ10376 HZ10557 HZ10715 HZ12005 HZ12057 HZ12107 HZ15118 HZ17068 HZ18134 HZ10051 HZ10190 HZ10378 HZ10560 HZ10717 HZ12006 HZ12058 HZ12108 HZ15480 HZ17069 HZ18142 HZ10052 HZ10194 HZ10379 HZ10562 HZ10722 HZ12007 HZ12059 HZ12125 HZ16006 HZ17070 HZ18143 HZ10054 HZ10196 HZ10387 HZ10568 HZ10724 HZ12008 HZ12060 HZ12126 HZ16069 HZ17071 HZ18155 HZ10055 HZ10201 HZ10392 HZ10580 HZ10728 HZ12009 HZ12061 HZ12154 HZ16070 HZ17072 HZ18175 HZ10058 HZ10203 HZ10394 HZ10584 HZ10730 HZ12010 HZ12062 HZ12188 HZ17001 HZ17074 HZ18188 HZ10061 HZ10205 HZ10398 HZ10591 HZ10731 HZ12011 HZ12063 HZ12190 HZ17002 HZ17078 HZ18193 HZ10063 HZ10209 HZ10401 HZ10592 HZ10733 HZ12012 HZ12064 HZ13006 HZ17003 HZ17079 HZ19001 HZ10065 HZ10210 HZ10403 HZ10594 HZ10737 HZ12013 HZ12065 HZ13009 HZ17006 HZ17081 HZ19003 HZ10068 HZ10220 HZ10404 HZ10598 HZ10740 HZ12015 HZ12066 HZ13013 HZ17007 HZ17106 HZ19004 HZ10070 HZ10228 HZ10408 HZ10601 HZ10743 HZ12016 HZ12067 HZ13019 HZ17010 HZ17118 HZ19005 HZ10073 HZ10237 HZ10409 HZ10607 HZ10744 HZ12018 HZ12068 HZ13020 HZ17011 HZ17126 HZ19006 HZ10076 HZ10239 HZ10411 HZ10609 HZ10759 HZ12019 HZ12069 HZ13021 HZ17012 HZ17137 HZ19007 HZ10083 HZ10240 HZ10412 HZ10611 HZ10762 HZ12020 HZ12070 HZ13022 HZ17013 HZ17142 HZ19010 HZ10084 HZ10242 HZ10425 HZ10612 HZ10764 HZ12021 HZ12071 HZ13023 HZ17016 HZ17175 HZ19012 HZ10086 HZ10245 HZ10426 HZ10613 HZ10766 HZ12022 HZ12072 HZ13024 HZ17017 HZ18001 HZ19013 HZ10088 HZ10247 HZ10430 HZ10617 HZ10771 HZ12023 HZ12073 HZ13026 HZ17018 HZ18002 HZ19014 HZ10090 HZ10249 HZ10434 HZ10620 HZ10774 HZ12024 HZ12074 HZ13029 HZ17019 HZ18004 HZ19015 HZ10092 HZ10254 HZ10438 HZ10627 HZ10776 HZ12026 HZ12075 HZ13030 HZ17020 HZ18006 HZ19017 HZ10095 HZ10257 HZ10442 HZ10629 HZ10778 HZ12027 HZ12076 HZ13031 HZ17021 HZ18013 HZ19018 HZ10098 HZ10258 HZ10450 HZ10632 HZ11001 HZ12028 HZ12077 HZ13032 HZ17023 HZ18018 HZ19019 HZ10102 HZ10260 HZ10453 HZ10640 HZ11002 HZ12029 HZ12078 HZ13038 HZ17024 HZ18020 HZ19020 HZ10108 HZ10271 HZ10460 HZ10644 HZ11003 HZ12030 HZ12080 HZ13039 HZ17027 HZ18022 HZ19022 HZ10110 HZ10273 HZ10467 HZ10646 HZ11004 HZ12031 HZ12081 HZ13041 HZ17028 HZ18024 HZ19023 HZ10116 HZ10274 HZ10479 HZ10647 HZ11005 HZ12032 HZ12082 HZ13042 HZ17030 HZ18026 HZ19025 HZ10117 HZ10283 HZ10489 HZ10649 HZ11006 HZ12033 HZ12083 HZ13043 HZ17032 HZ18035 HZ19026 HZ10121 HZ10293 HZ10493 HZ10650 HZ11007 HZ12034 HZ12084 HZ13044 HZ17034 HZ18040 HZ19028 HZ10126 HZ10294 HZ10495 HZ10652 HZ11008 HZ12035 HZ12085 HZ13045 HZ17035 HZ18041 HZ19029 HZ10138 HZ10295 HZ10496 HZ10656 HZ11010 HZ12036 HZ12086 HZ13046 HZ17036 HZ18042 HZ19033 HZ10144 HZ10297 HZ10497 HZ10659 HZ11011 HZ12037 HZ12087 HZ13047 HZ17037 HZ18043 HZ19034 HZ10146 HZ10299 HZ10500 HZ10663 HZ11013 HZ12038 HZ12088 HZ13048 HZ17039 HZ18046 HZ19035 HZ10148 HZ10303 HZ10501 HZ10665 HZ11014 HZ12039 HZ12089 HZ13049 HZ17040 HZ18048 HZ19036 HZ19040 HZ19041 HZ19043 HZ19044 HZ19045 HZ19046 HZ19051 HZ19052 HZ19053 HZ19055 HZ19056 HZ19059 HZ19060 HZ19062 HZ19065 HZ19066 HZ19068 HZ19069 HZ19071 HZ19072 HZ19076 HZ19078 HZ19079 HZ19086 HZ19087 HZ19088 HZ19089 HZ19091 HZ19095 HZ19096 HZ19098 HZ19099 HZ19104 HZ19106 HZ19109 HZ19113 HZ19114 HZ19115 HZ19117 HZ19118 HZ19119 HZ19121 HZ19125 HZ19126 HZ19128 HZ19129 HZ19130 HZ19131 HZ19133 HZ19134 HZ19135 HZ19140 HZ19141 HZ19142 HZ19143 HZ19155 HZ19158 HZ19159 HZ19162 HZ19167 HZ19170 HZ19171 HZ19172 HZ19179 HZ19186 HZ19189 HZ19190 HZ19193 HZ19194 HZ19195 HZ19201 HZ19226 HZ19227 HZ19228 HZ19229 HZ19235 HZ19236 HZ19611 HZ19926 HZ19996 HZ19997 HZ19998
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated March 3, 2011. Firm initiated recall is ongoing.
REASON
The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.
VOLUME OF PRODUCT IN COMMERCE
599 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications. Recall # Z-2182-2011
CODE
Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002
RECALLING FIRM/MANUFACTURER
KCI USA, Inc., San Antonio, TX, by letter on February 23, 2011. Firm initiated recall is ongoing.
REASON
Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.
VOLUME OF PRODUCT IN COMMERCE
229 units
DISTRIBUTION
Nationwide and Kuwait
___________________________________
PRODUCT
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature. Recall # Z-2183-2011
CODE
Unit #’s: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remote Diagnostic Technologies Ltd., Basingstoke, Hampshire, United Kingdom, by letter on March 25, 2011.  
Manufacturers: Remote Diagnostic Technologies Ltd., Basingstoke Hampshire, United Kingdom;
Qrs Diagnostic, Maple Grove, MN.
Firm initiated recall is ongoing.
REASON
It was discovered that when a 12 Lead ECG is recorded and monitoring is quickly restarted, the ECG can cease functioning.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IGFBP-3 ELISA Reagent Kit; Part Number: DSL-10-6600. This assay is intended for in vitro diagnostic use. Recall # Z-2184-2011
CODE
Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on March 30, 2011.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).
VOLUME OF PRODUCT IN COMMERCE
1,212 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize the RT Therapist v4.1 software. The intended use is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. ARTIST Systems include: Therapist Express Basic Part number 08515289; Therapist Express Assist Part number 08515297; syngo RT Therapist Assist Part number 08162807; syngo RT Therapist Part number 08162815; and sysno RT Therapist connect/MPSAOQ OIS Part number 08168754. Recall # Z-2190-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 24, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
When using the ARTISTE Linac and RT Therapist v4.1 along with an imported cropped reference image, the image maybe processed incorrectly, thus resulting in a mistreatment.
VOLUME OF PRODUCT IN COMMERCE
228 active devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile.  Made in USA for use in aspiration of medications, typically in the pharmacy setting. Recall # Z-2192-2011
CODE
Lot# 0007829
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on March 1, 2011 and March 2, 2011.
Manufacturer: BD Medical Surgical, Columbus, NB. Firm initiated recall is ongoing.
REASON
Incorrect unit package labels which reflect Reorder #305216 instead of the correct item, Reorder #305213, were used.
VOLUME OF PRODUCT IN COMMERCE
161,000 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Curad Flex-Fabric/Tissu Souple, 3/4 x 3 in., 100 sterile adhesive bandages, Made in China. Recall # Z-2198-2011
CODE
Lot No. 100A229 and 100A212
RECALLING FIRM/MANUFACTURER
Jiangsu Wujin Hualian Health Dressing Co., Ltd., Wujin City, Jiangsu Prov., China, by e-mail and a letter, dated March 18, 2011. Firm initiated recall is ongoing.
REASON
The sterility of the product has the potential to be compromised due to weak sealing of the bandages.
VOLUME OF PRODUCT IN COMMERCE
756 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions. Recall # Z-2200-2011
CODE
Units: HZlOOO3 HZlO153 HZI0313 HZI0513 HZI0679 HZl1020 HZ12046 HZ12097 HZ13059 HZ17058 HZ18118 HZlOOO8 HZI0154 HZ10316 HZI0528 HZlO681 HZl1021 HZ12047 HZ12098 HZ13060 HZ17059 HZ18120 HZIOO13 HZI0155 HZ10326 HZI0534 HZI0684 Zl1022 HZ12048 HZ12099 HZ13062 HZ17061 HZ18126 HZIOO14 HZI0157 HZ10330 HZI0537 HZ10685 HZl1023 HZ12049 HZl2100 HZ13063 HZ17062 HZ18131 HZlOO15 HZI0159 HZI0333 HZ10540 HZ10689 HZl1024 HZ12050 HZl2101 HZ13064 HZ17065 HZ18132 HZIOO17 HZI0165 HZI0335 HZI0541 HZ10693 HZl1025 HZ12051 HZl2102 HZ15006 HZ17067 HZ18134 HZIOO19 HZI0170 HZI0337 HZ10542 HZI0698 HZ12001 HZ12052 HZ12103 HZ15070 HZ17068 HZ18142 HZIOO23 HZlOl72 HZI0343 HZI0544 HZ10700 HZ12002 HZ12054 HZ12104 HZ15118 HZ17069 HZ18143 HZlOO24 HZI0179 HZ10347 HZ10545 HZI0703 HZ12003 HZ12056 HZ12107 HZ15480 HZ17070 HZ18155 HZlOO25 HZI0181 HZI0352 HZ10547 HZ10706 HZ12004 HZ12057 HZ12108 HZ16006 HZ17071 HZ18175 HZIOO26 HZI0182 HZI0357 HZ10552 HZI0712 HZ12005 HZ12058 HZ12125 HZ16069 HZ17072 HZ18188 HZIOO27 HZI0183 HZI0368 HZ10553 HZlO715 HZ12006 HZ12059 HZ12126 HZ16070 HZ17074 HZ18193 HZIOO29 HZI0185 HZI0372 HZI0557 HZI0717 HZ12007 HZl2060 HZ12154 HZ17001 HZ17078 HZ19001 HZIOO44 HZI0187 HZ10376 HZI0560 HZI0722 HZ12008 HZ12061 HZ12188 HZ17002 HZ17079 HZ19003 HZIOO46 HZI0188 HZ10378 HZI0562 HZI0724 HZ12009 HZ12062 HZ12190 HZ17003 HZ17081 HZ19004 HZlOO48 HZI0190 HZ10379 HZ10568 HZlO728 HZ12010 HZ12063 HZ13006 HZ17006 HZ17106 HZ19cio5 HZIOO51 HZI0194 HZI0387 HZ10580 HZ10730 HZ12011 HZ12064 HZ13009 HZ17007 HZ17118 HZ19006 HZlOO52 HZI0196 HZI0392 HZI0584 HZ10731 HZ12012 HZ12065 HZ13013 HZ17010 HZl7126 HZ19007 HZlOO54 HZ10201 HZI0394 HZI0591 HZ10733 HZ12013 HZ12066 HZ13019 HZ17011 HZ17137 HZ19010 HZIOO55 HZ10203 HZ10398 HZI0592 HZI0737 HZ12015 HZ12067 HZ13020 HZ17012 HZl7142 HZ19012 HZIOO58 HZ10205 HZI0401 HZI0594 HZI0740 HZ12016 HZ12068 HZ13021 HZ17013 HZl7175 HZ19013 HZIOO61 HZI0209 HZI0403 HZI0598 HZI0743 HZ12018 HZ12069 HZ13022 HZ17016 HZ18001 HZ19014 HZlOO63 HZ10210 HZ10404 HZ10601 HZ10744 HZ12019 HZ12070 HZ13023 HZ17017 HZ18002 HZ19015 HZlOO65 HZ10220 HZ10408 HZI0607 HZI0759 HZ12020 HZ12071 HZ13024 HZ17018 HZ18004 HZ19017 HZIOO68 HZI0228 HZI0409 HZI0609 HZI0762 HZ12021 HZ12072 HZ13026 HZ17019 HZ18006 HZ19018 HZIOO70 HZI0237 HZI0411 HZI0611 HZI0764 HZ12022 HZ12073 HZ13029 HZ17020 HZ18013 HZ19019 HZIOO73 HZI0239 HZ10412 HZ10612 HZ10766 HZ12023 HZ12074 HZ13030 HZ17021 HZ18018 HZ19020 HZlOO76 HZI0240 HZI0425 HZI0613 HZI0771 HZ12024 HZ12075 HZ13031 HZ17023 HZ18020 HZ19023 HZlOO83 HZ10242 HZ10426 HZ10617 HZI0774 HZ12026 HZ12076 HZ13032 HZ17024 HZ18022 HZ19025 HZIOO84 HZ10245 HZI0430 HZI0620 HZI0776 HZ12027 HZ12077 HZ13038 HZ17027 HZ18024 HZ19026 HZlOO86 HZ10247 HZI0434 HZI0627 HZI0778 HZ12028 HZ12078 HZ13039 HZ17028 HZ18026 HZ19028 HZIOO88 HZI0249 HZI0438 HZI0629 HZll001 HZ12029 HZ12080 HZ13041 HZ17030 HZ18035 HZ19029 HZlOO90 HZI0254 HZI0442 HZI0632 HZll002 HZ12030 HZ12081 HZ13042 HZ17032 HZ18040 HZ19033 HZIOO92 HZI0257 HZI0450 HZI0640 HZll003 HZ12031 HZ12082 HZ13043 HZ17034 HZ18041 HZ19034 HZlOO95 HZI0258 HZI0453 HZI0644 HZll004 HZ12032 HZ12083 HZ13044 HZ17035 HZ18042 HZ19035 HZIOO98 HZI0260 HZI0460 HZI0646 HZll005 HZ12033 HZ12084 HZ13045 HZ17036 HZ18043 HZ19036 HZIOI02 HZ10271 HZI0467 HZI0647 HZll006 HZ12034 HZ1208 HZ13046 HZ17037 HZ18046 HZ19040 HZIOI08 HZI0273 HZI0479 HZI0649 HZll007 HZ12035 HZ12086 HZ13047 HZ17039 HZ18048 HZ19041 HZIOll0 HZ10274 HZI0489 HZI0650 HZll008 HZ12036 HZ12087 HZ13048 HZ17040 HZ18062 HZ19043 HZI0116 HZI0283 HZ10493 HZ10652 HZll010 HZ12037 HZ12088 HZ13049 HZ17041 HZ18066 HZ19044 HZI0117 HZI0293 HZI0495 HZ10656 HZll0ll HZ12038 HZ12089 HZ13050 HZ17042 HZ18068 HZ19045 HZI0121 HZlO294 HZI0496 HZI0659 HZll013 HZ12039 HZ12090 HZ13052 HZ17043 HZ18069 HZ19046 HZI0126 HZI0295 HZ10497 HZI0663 HZll014 HZ12040 HZ12091 HZ13053 HZ17044 HZ18070 HZ19051 HZI0138 HZI0297 HZI0500 HZ10665 HZll015 HZ12041 HZ12092 HZ13054 HZ17046 HZ18076 HZ19052 HZI0144 HZ10299 HZ10501 HZ10670 HZll016 HZ12042 HZ12093 HZ13055 HZ17048 HZ18077 HZ19053 HZlO146 HZlO303 HZI0507 HZI0674 HZll017 HZ12043 HZ12094 HZ13056 HZ17049 HZ18079 HZ19055 HZlO148 HZI0305 HZI0508 HZI0675 HZll018 HZ12044 HZ12095 HZ13057 HZ17051 HZ18085 HZ19056 HZlO151 HZI0311 HZI0509 HZI0676 HZll019 HZ12045 HZ12096 HZ13058 HZ17057 HZ18088 HZ19059 HZ19060 HZ19086 HZl9109 HZ19129 HZ19158 HZ19193 HZ19926 HZ19062 HZ19087 HZ19113 HZ19130 HZ19159 HZ19194 HZ19996 HZ19065 HZ19088 HZ19114 HZ19131 HZ19162 HZ19195 HZ19997 HZ19066 HZ19089 HZ19115 HZ19133 HZ19167 HZ19201 HZ19998 HZl9068 HZ19091 HZl9117 HZ19134 HZ19170 HZ19226 HZ19069 HZ19095 HZ19118 HZ19135 HZ19171 HZ19227 HZ19071 HZ19096 HZ19119 HZ19140 HZ19172 HZ19228 HZ19072 HZ19098 HZ19121 HZ19141 HZ19179 HZ19229 HZ19076 HZ19099 HZ19125 HZ19142 HZ19186 HZ19235 HZ19078 HZ19104 HZ19126 HZ19143 HZl9189 HZ19236 HZ19079 HZ19106 HZ19128 HZ19155 HZ19190 and HZ19611
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on March 30, 2011. Firm initiated recall is ongoing.
REASON
A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system result in a lateral offset error.
VOLUME OF PRODUCT IN COMMERCE
598 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound. Recall # Z-2203-2011
CODE
Units: W1A0822031-33, W1A0822048-49, W1A0832056, W1A0842069-70, W1B0852071-80, W1B0862087-8, W1C0872103-08, W1C0882119-24, W1F0972204-06, W1F0972218-20, W1F0992260-62, W1F0992268, and W1F0992270-73
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc, Tustin, CA, by letter on January 6, 2010. 
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
Toshiba America Medical Systems (TAMS) has become aware that the FLEX M software has reversed left and right annotation and post FLEX M measurement error, which may result in incorrect values.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed. Recall # Z-2204-2011
CODE
Serial Numbers: 2089, 2114, 2302, 3204, 2037, 2014, 2040, 2898, 2054, 2042, 2067, 2202, 2241, 2100, 2038, 2101, 2102, 2244, 2097, 2931, 2900, 3085, 2412, 2595, 2106, 2041, 2108, 2113, 2130, 2135, 2147, 2158, 2063, 2157, 2161, and 2243
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter, dated April 6, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
The recall was initiated by Toshiba America Medical Systems (TAMS) because the software associated with TSX-101A: Aquilion 64 can prevent scanning from being performed at the specified helical pitch (couch movement speed).
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX. Recall # Z-2402-2011
CODE
Lot number: 245104
RECALLING FIRM/MANUFACTURER
Biosite Inc Dba Innovacon, Inc., San Diego, CA, by letter on February 18, 2011. Firm initiated recall is ongoing.
REASON
The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of the specimen.
VOLUME OF PRODUCT IN COMMERCE
5,305 Boxes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104146. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2421-2011;
 
2) Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104148. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2422-2011;
 
3) Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2423-2011;
 
4) Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104152. Intended Use: The Porous Plasma Spray (PPS) Ringloc a Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2424-2011;
 
5) Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104154. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2425-2011;
 
6) Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall #Z-2426-2011;
 
7) Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104158. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2427-2011;
 
8) Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, sterile, REF 16-104160. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2428-2011;
 
9) Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104162. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2429-2011;
 
10) Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented use, sterile, REF 16-104164. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2430-2011;
 
11) Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, sterile, REF 16-104166. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2431-2011;
 
12) Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented use, sterile, REF 16-104170. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2432-2011;
 
13) Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-116046. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2433-2011;
 
14) Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, REF 16-116048. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2434-2011;
 
15) Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116050. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2435-2011;
 
16) Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, REF 16-116052. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2436-2011;
 
17) Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116054. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2437-2011;
 
18) Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116056. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2438-2011;
 
19) Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116058. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2439-2011;
 
20) Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116060. Recall # Z-2440-2011;
 
21) Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116062. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2441-2011;
 
22) Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116064. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2442-2011;
 
23) Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116066. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2443-2011;
 
24) Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, sterile, REF 16-116068. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2444-2011;
 
25) Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116070. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2445-2011;
 
26) Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116072. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2446-2011;
 
27) Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116076. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2447-2011;
 
28) Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, sterile, REF PT-104050. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2448-2011;
 
29) Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring w/Plug, sterile, REF PT-104052. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2449-2011;
 
30) Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring w/Plug, sterile, REF PT-104056. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2450-2011;
 
31) Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, sterile, REF PT-104062. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2451-2011;
 
32) Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring w/Plug, sterile, REF PT-104064. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2452-2011;
 
33) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, sterile, REF PT-106054. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2453-2011;
 
34) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, sterile, REF PT-106056. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2454-2011;
 
35) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT-106060. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2455-2011;
 
36) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT-106062. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2456-2011;
 
37) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT-106064. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2457-2011;
 
38) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT-106066. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2458-2011;
 
39) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT-106070. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2459-2011;
 
40) Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT-106074. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2460-2011;
 
41) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, REF PT-116048. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall #Z-2461-2011;
 
42) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, REF PT-116050. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2462-2011;
 
43) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, REF PT-116052. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2463-2011;
 
44) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, REF PT-116054. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2464-2011;
 
45) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, REF PT-116056. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall# Z-2465-2011
 
46) Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, REF PT-116060. Intended Use: The Regenerex Ringloc is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Recall # Z-2466-2011
CODE
1) Lot number: M582210;
 
2) Lot number: M105210, M181710, M211040, M582230, M618540, M618560 and M618570;
 
3) Lot numbers: M011320, M011340, M020960, M105260, M361280, M379570, M379580, M482310, M482330, M482340, M583540, M618580, M618910, M815740, M815750, M857250, M888560, M888590, M971590, M971600 and M971680;
 
4) Lot numbers M022740, M022750, M134000, M379640, M387770, M387780, M387800, M387810, M423630, M618930, M743160, M888610, M888620 and M988780;
 
5) Lot numbers; M059630, M065810, M065820, M074220, M082510, M082530, M181820, M387830, M387850, M387870, M423730, M482410, M592100, M592150, M743190, M903070, M903080, M903090, M971770 and M061150;
 
6) Lot numbers: M048180, M061180, M061190, M276160, M276170, M276180, M299730, M383260, M383290, M383300, M874150, M903110, M903160, M903180, M903190, M903200, M903220, M903230, and M048200;
 
7) Lot numbers: M037190, M037200, M099460, M248730, M383170, M780920, M780940, M845270 and M997110;
 
8) Lot numbers: M037210, M037230, M099350, M248780, M684480, M727820 and M900900;
 
9) Lot numbers: M208530, M565150 and M726020;
 
10) Lot number: M565190;
 
11) Lot numbers: M565200 and M704090;
 
12) Lot number: M684510;
 
13) Lot number: M181150, M582250, M582270, M964240 and M964260;
 
14) Lot numbers: M116440, M482360 and M971640;
 
15) Lot numbers: M815760 and M883550;
 
16) Lot numbers: M181200, M686190, M883600 and M163280;
 
17) Lot numbers: M181350, M181360 and M971730;
 
18) Lot numbers: M010360, M144400, M160860, M510780, M592160 and M592170;
 
19) Lot numbers: M510790, M510800, M799990, M903250 and M089400;
 
20) Lot numbers: M510810, M510820 and M845540;
 
21) Lot numbers: M089420, M231940, M248870, M248880, M510830, M510840 and M727080;
 
22) Lot numbers: M425920, M523990, M704130, M845780 and M845790;
 
23) Lot numbers: M524000, M524010, M704140, M771850 and M198000;
 
24) Lot numbers: M099270, M099280, M239660 and M704180;
 
25) Lot numbers: M042040, M248890 and M704200;
 
26) Lot numbers: M684530 and M240570;
 
27) Lot number: M010390;
 
28) Lot numbers: M415100 and M415110;
 
29) Lot number: M817580;
 
30) Lot numbers: M181860 and M482480;
 
31) Lot numbers: M299860 and M520400;
 
32) Lot number: M299890;
 
33) Lot number: M181900 and M817680;
 
34) Lot numbers: M084210 and M120080;
 
35) Lot number: M376240;
 
36) Lot numbers: M103730 and M530430;
 
37) Lot number: M223630;
 
38) Lot number: M223640;
 
39) Lot number: M223650;
 
40) Lot number: M103760;
 
41) Lot numbers: M561090, M561200;
 
42) Lot numbers: M424030, M561440, M561460;
 
43) Lot number: M991010;
 
44) Lot number: M817750;
 
45) Lot numbers: M424000, M685940, M730870, M730880;
 
46) Lot numbers: M423910 M686060
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated 14, 2011. Firm initiated recall is ongoing.
REASON
The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.
VOLUME OF PRODUCT IN COMMERCE
762 units
DISTRIBUTION
Nationwide, Australia, Netherlands and Japan
___________________________________
PRODUCT
Contact Nipple Shield (Sterile) - 24mm (Standard); individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; article #67203S individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby. Article number 67203S. Recall # Z-2553-2011
CODE
Lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medela Inc., Mchenry, IL, by letter dated May 9, 2011.
Manufacturers: Medela Inc., Mchenry, IL;  
Silcotech AG - Precision Silicon Parts, Switzerland. FDA initiated recall is ongoing.
REASON The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
VOLUME OF PRODUCT IN COMMERCE
4,320 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer. Recall # Z-2558-2011
CODE
Lot numbers 038811 and 102812
RECALLING FIRM/MANUFACTURER
OPTI Medical Systems, Inc., Roswell, GA, by letter dated March 15, 2011. Firm initiated recall is ongoing.
REASON
The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
VOLUME OF PRODUCT IN COMMERCE
86 boxes (25 units /per box)
DISTRIBUTION
Nationwide, India, Lebanon, Philippines, Sweden, Venezuela and Vietnam
___________________________________
PRODUCT
Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall # Z-2560-2011
CODE
XiO Release 1.0.0 through 1.0.2 All lot or serial numbers
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated June 2008. Firm initiated recall is ongoing.
REASON
Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other indication that this had occurred. All plan parameters and output will still indicate that Monte Carlo Photon was the intended algorithm for final dose.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software. The Centricity Laboratory is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and report processing. The centricity is intended to interface with various lab devices through standard HL7 interfaces to record, report and distribute lab results. Recall # Z-2563-2011
CODE
Versions 3.3, 4.0 and 4.1
RECALLING FIRM/MANUFACTURER
GE Healthcare IT, Barrington, IL, by letter dated May 3, 2011. Firm initiated recall is ongoing.
REASON
The GE Centricity Laboratory Instrument Interface to Data Innovations is processing a preliminary result instead of the final result from the Process System Manager when there is a test rerun conducted.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide, Canada, England, and Qatar
___________________________________
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2567-2011
CODE
XiO Release 4.3.1 through 4.40.00. All lot or serial numbers.
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, letter dated December 8, 2008. Firm initiated recall is ongoing.
REASON
XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Release 4.3.1.
VOLUME OF PRODUCT IN COMMERCE
784 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb and FHbF). Recall # Z-2571-2011
CODE
All lot numbers between 319 and 325 942-060, all lot numbers between 159 and 252
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated April 14, 2011.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used for the diagnosis and therapy of patients with hypocalcaemia.
VOLUME OF PRODUCT IN COMMERCE
30,323 boxes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 VM8 863066, 863068, 453564022081, 453564024461, 453564024481 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-2583-2011;
 
2) Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261, VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-2584-2011
CODE
1) Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546;
 
2) Serial Number Range CN04400000 - CN04499999 US10200000 - US10299999 CN03700000 - CN03799999 CN04400000 - CN04499999 CN10200000 - CN10299999 US03800000 - US03899999 US04400000 - US04499999 US10200000 - US10299999
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated May 2011. Firm initiated recall is ongoing.
REASON
Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of audible sound.
VOLUME OF PRODUCT IN COMMERCE
5,740 units
DISTRIBUTION
Nationwide and Internationally
 
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, UPC # 7 80872 07003 4". Recall # V-112-2011
CODE
The recalled product is from the firm's Lot #3189 which is their Purchase Order number of the imported product.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pet Appeal, Inc., Clackamas, OR, by telephone on December 28, 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 22, 2011
 
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