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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 8, 2010

September 8, 2010                                                                                        10-35

 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Macadamia nuts in 25 lb. Box. Recall #F-2802-2010
CODE
Lot code RF101
RECALLING FIRM/MANUFACTURER
Kennfoods USA, LLC, San Leandro, CA, by telephone and letter on July 30, 2010. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,400 lbs
DISTRIBUTION
NY and CA
___________________________________
PRODUCT
KCB Cake Rusk, No Eggs Added; Net Weight: 800 gr, 28 oz. Recall # F-2803-2010
CODE
Exp 2/1/11, UPC: 2 12042 00109 9
RECALLING FIRM/MANUFACTURER
Kashmir Crown Baking LLC, Linden NJ, by e-mails and letters on July 23, 2010 and press release on August 2, 2010. Firm initiated recall is ongoing.
REASON
Recall was initiated after a consumer complaint was received by the firm stating that their child, who is allergic to eggs, had an allergic reaction after consuming the No Eggs Added product.
VOLUME OF PRODUCT IN COMMERCE
73 x 28 oz. packages
DISTRIBUTION
MD, NC, NY and NJ
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Folic Acid 1000 mcg - 1000 Tablets per bottle UPC: 0 79854 51280 9). NDC # 54629-012800, Stock No. 1280. Recall # F-2801-2010
CODE
Lot number: 9KB31 EXP: 12/12
RECALLING FIRM/MANUFACTURER
National Vitamin Co Inc., Casa Grande, AZ, by letter on May 21, 2010. Firm initiated recall is ongoing.  
REASON
The product may contain a foreign capsule.
VOLUME OF PRODUCT IN COMMERCE
3,265 bottles with 1,000 tablets each
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT   
APS Coumadin (Warfarin Sodium Tablets, USP) Crystalline 1mg, 100UD, unit NDC #0056-0169-75, Dose NDC #0056-0169-01. Recall # D-800-2010
CODE
Lot #, 084982, Exp. Date, 06/2011; Lot #, 090200, Exp. Date, 06/2011; Lot #, 090300, Exp. Date, 06/2011; Lot #, 090468, Exp. Date, 06/2011; Lot #, 093585, Exp. Date, 12/2011; Lot # 095406, Exp. Date, 01/2012; Lot #, 097000, Exp. Date, 01/2012; Lot #, 100165, Exp. Date, 06/2012; Lot #, 100585, Exp. Date, 06/2012 & Lot #, 101565, Exp. Date, 11/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on August 18, 2010.
Manufacturer: Bristol Myers Squibb Holdings Pharma, Ltd., Manati, PR. Firm initiated recall is ongoing.
REASON
This sub-recall was initiated to comply with Bristol-Myers Squibb recall (dated June 25, 2010) that was determined that some tablets, over time, may not meet specifications for isopropanol, which is required to maintain the active ingredient in a crystalline state.
VOLUME OF PRODUCT IN COMMERCE
244 units/100/1 mg tablets
DISTRIBUTION
AZ, GA, IL, MI, NC, PA, VA
___________________________________
PRODUCT   
Pulmolite (Kit for the Preparation of Technetium Tc99m Albumin Aggregated Injection), 10 mL vials, a) 5 vial kit (NDC 45567-0415-1), b) 30 vial kit (NDC 45567-0415-2), Rx only. Recall # D-801-2010
CODE
Lot 160034, Exp. 10/31/2010
RECALLING FIRM/MANUFACTURER
Pharmalucence, Inc., Bedford, MA, by phone and by e-mail on July 22, 2010. Firm initiated recall is ongoing.
REASON
Product Lacks Stability: Product does not meet stability to expiration date and exhibits low particle counts which could lead to a non-diagnostic scan.
VOLUME OF PRODUCT IN COMMERCE
15,110 vials (5 vial kits: 376; 30 vial kits: 441)
DISTRIBUTION
Nationwide, Australia
___________________________________
PRODUCT   
1) L-Cysteine Hydrochloride Injection, USP 50 mg/ml (10 ml fill in 10 ml vials, package of 10 vials.; NDC# 0703-5324-03); 10 ml vials, individual vial; NDC# 0703-5324-01).The lots were distributed under the Sicor Label and not the Teva Parenterals Medicines Inc. label. Recall # D-802-201;
 
2) L-Cysteine Hydrochloride Injection, USP 50 mg/ml (50 ml fill in 50 ml vials , package of 10 vials. NDC# 0703-5328-03) and 10 ml vials, individual vial- NDC# 0703-5328-01) The lots were distributed under the Sicor Label and not the Teva Parenterals Medicines Inc. label. Recall # D-803-2010
CODE
1) Lot # 07P135, EXP 11/2010, Lot # 31302376B, EXP 05/2011, Lot # 31304792B, EXP 11/2011, Lot # 31305667B, EXP 01/2012;
 
2) Lot # 07P135, EXP 11/2010, Lot # 31302376B, EXP 05/2011, Lot # 31304792B, EXP 11/2011, Lot # 31305667B, EXP 01/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letters on April 28, 2010.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
CGMP Deviation: Absence of stability indicating methods for assay and impurities.
VOLUME OF PRODUCT IN COMMERCE
750,310
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Buphenyl (sodium phenylbutyrate) Powder, 250 grams in a 500 cc bottle; Rx only; NDC 62592-188-64. Recall # D-804-2010
CODE
Lots 3272.059, 3272.060 and 3272.061
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medicis Pharmaceutical Corp., Scottsdale AR, by letter on July 23, 2010.
Manufacturer: Lyne Laboratories, Inc., Brockton, MA. Firm initiated recall is ongoing. 
REASON
Subpotent - The recall was initiated after recent tests showed that bottles from lots 3272.059, 3272.060 and 3272.061 could present a 3-9% under dosing to the patient.
VOLUME OF PRODUCT IN COMMERCE
568 bottles
DISTRIBUTION
CT, GA, KY, NV, NY, PA, Canada & South Africa
___________________________________
PRODUCT   
1) CONCENTRATED TYLENOL(R) INFANTS' DROPS GRAPE FLAVOR in 1 OZ. (NDC 50580-144-01) and 0.5 OZ. (NDC 50580-144-15) containers. Recall # D-806-2010;
 
2) CONCENTRATED TYLENOL(R) INFANTS' DROPS 1 OZ. CHERRY DYE FREE (NDC 50580-167-01). Recall # D-807-2010;
 
3) CONCENTRATED TYLENOL(R) INFANTS' DROPS CHERRY FLAVOR in 0.5 OZ. (NDC 50580-143-15) and 1 OZ. (NDC 50580-143-30) containers. Recall # D-808-2010;
 
4) CONCENTRATED TYLENOL(R) INFANTS' DROPS 0.5 OZ. GRAPE - HOSPITAL (NDC 50580-144-18). Recall # D-809-2010;
 
5) CONCENTRATED TYLENOL(R) INFANTS' DROPS 0.25 OZ. GRAPE - SAMPLE (NDC 50580-144-40). Recall # D-810-2010;
 
6) CHILDREN'S TYLENOL(R) SUSPENSION CHERRY BLAST FLAVOR in 2 OZ. (NDC 50580-123-02) and 4 OZ. (NDC 50580-123-04). Recall # D-811-2010;
 
7) CHILDREN'S TYLENOL(R) DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR (NDC 50580-166-04). Recall # D-812-2010;  
 
8) CHILDREN'S TYLENOL(R) SUSPENSION 4 OZ. GRAPE SPLASH (NDC 50580-296-04). Recall # D-813-2010;
 
9) CHILDREN'S TYLENOL(R) SUSPENSION 4 OZ. BUBBLEGUM FLAVOR (NDC 50580-407-04). Recall # D-814-2010;
 
10) CHILDREN'S TYLENOL(R) SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR (NDC 50580-493-04). Recall # D-815-2010;
 
11) CHILDREN'S TYLENOL(R) SUSPENSION CHERRY BLAST FLAVOR in 1 OZ. SAMPLES (NDC 50580-123-01) and 4 OZ. HOSPITAL (NDC 50580-123-03) containers. Recall # D-816-2010;
 
12) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR (NDC 50580-247-04). Recall # D-817-2010;
 
13) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR (NDC 50580-249-04). Recall # D-818-2010;
 
14) CHILDREN'S TYLENOL(R) PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR (NDC 50580-253-04). Recall # D-819-2010;
 
15) CHILDREN'S TYLENOL(R) PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR (NDC 50580-254-04). Recall # D-820-2010;
 
16) CHILDREN'S TYLENOL(R) PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR (NDC 50580-255-04). Recall # D-821-2010;
 
17) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR (NDC 50580-386-04). Recall # D-822-2010;
 
18) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR (NDC 50580-387-04). Recall # D-823-2010;
 
19) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR (NDC 50580-390-04). Recall # D-824-2010;
 
20) CHILDREN'S TYLENOL(R) PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR (NDC 50580-391-04). Recall # D-825-2010;
 
21) CONCENTRATED MOTRIN(R) INFANTS' DROPS BERRY DYE FREE in 1 OZ. (NDC 50580-198-01) and 0.5 OZ. (NDC 50580-198-15). Recall # D-826-2010;
 
22) CONCENTRATED MOTRIN(R) INFANTS' DROPS 0.5 OZ. BERRY FLAVOR (NDC 50580-100-15). Recall # D-827-2010;
 
23) CHILDREN'S MOTRIN(R) SUSPENSION 4 OZ. BERRY DYE FREE (NDC 50580-184-04). Recall # D-828-2010;
 
24) CHILDREN'S MOTRIN(R) SUSPENSION BERRY FLAVOR in 2 OZ. (NDC 50580-601-02) and 4 OZ. (NDC 50580-601-04 ). Recall # D-829-2010;
 
25) CHILDREN'S MOTRIN(R) SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR (NDC 50580-215-04). Recall # D-830-2010;
 
26) CHILDREN'S MOTRIN(R) SUSPENSION GRAPE FLAVOR in 4 OZ. (NDC 50580-603-04) and 1 OZ. SAMPLE (NDC 50580-603-01). Recall # D-831-2010;
 
27) CHILDREN'S MOTRIN(R) SUSPENSION BUBBLEGUM FLAVOR in 4 OZ. (NDC 50580-604-04) and 1 OZ. SAMPLE (NDC 50580-604-01). Recall # D-832-2010;
 
28) CHILDREN'S MOTRIN(R) SUSPENSION BERRY in 1 OZ. SAMPLE (NDC 50580-601-01) and 4 OZ. HOSPITAL (NDC 50580-601-50). Recall # D-833-2010;
 
29) CHILDREN'S MOTRIN(R) SUSPENSION 4 OZ. COLD BERRY FLAVOR (NDC 50580-902-04). Recall # D-834-2010;
 
30) CHILDREN'S ZYRTEC(R) 4 OZ. BUBBLEGUM DYE FREE SUGAR FREE SYRUP (NDC 50580-721-04). Recall # D-835-2010.
 
31) CHILDREN'S ZYRTEC(R) DYE FREE SUGAR FREE 4 OZ. GRAPE SYRUP (NDC 50580-730-04). Recall # D-836-2010;
 
32) CHILDREN'S ZYRTEC(R) SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE (NDC 50580-730-15). Recall # D-837-2010;
 
33) CHILDREN'S ZYRTEC(R) SUGAR-FREE DYE-FREE BUBBLEGUM in 0.5 OZ (NDC 50580-721-15) and 2 X 4 OZ. (NDC 50580-721-08). Recall # D-838-2010;
 
34) CHILDREN'S ZYRTEC(R) PERFECT MEASURE (pre-filled spoons). Recall # D-839-2010;
 
35) CHILDREN'S BENADRYL(R) ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID (NDC 50580-535-04). Recall # D-840-2010;
 
36) JOHNSON'S BABY RELIEF KIT contains CONCENTRATED TYLENOL(R) INFANTS' DROPS 0.5 OZ. GRAPE FLAVOR (NDC 50580-144-15) and/or CONCENTRATED MOTRIN(R) INFANTS' DROPS 0.5 OZ. BERRY (NDC 50580-100-15) Recall # D-841-2010
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by press release on April 30, 2010 and letter on May 1, 2010.
Manufacturer: Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA. Firm initiated recall is ongoing.     
REASON
GMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
168,820,736 bottles
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT   
Clindamycin Injection USP, 150 mg/mL (9 Grams per 60 mL), 60 mL Pharmacy Bulk Package Vial, Rx only, NDC 55390-109-01. Recall D-799-2010
CODE
Lot #'s: 2258-58-1355550, Exp 10/10; 2258-58-1382729, Exp 11/10; and 2258-58-1865326, Exp 01/12
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc., Bedford, OH, by letters on August 11, 2010. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): Trace quantities of n-paraffin were found in the Clindamycin Phosphate Active Pharmaceutical Ingredient (API) by the API manufacturer.
VOLUME OF PRODUCT IN COMMERCE
53,051 pharmacy bulk vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Loratadine orally disintegrating tablets, 10 mg, OTC; The product was distributed under the following labels: 1) CareOne Allergy Relief, i) 10 Tablets Count Box, NDC 41520-311-52, UPC 3 41520 31346 2; ii) 24 Tablets Count Box, NDC 41520-824-62, UPC 3 41520 31349 3; 2) Good Neighbor Pharmacy, Allergy Relief, i) 10 Tablets Count Box, NDC 24385-518-52, UPC 0 87701 93203 8; ii) 12 Tablets Count Box, NDC 24385-540-53, UPC 0 87701 96447 3; 3) H.E.B. Allergy Relief, 10 Tablets Count Box, NDC 37808-311-52, UPC 0 41220 98534 0; 4) HyVee Allergy Relief, i) 12 Tablets Count Box, NDC 42507-824-53, UPC 0-75450 29312 8; ii) 24 Tablets Count Box, NDC 42507-824-62, UPC 0 75450 29313 5; 5) American Fare Allergy Relief, 12 Tablets Count Box, NDC 49738-824-53, UPC 0 72000 18989 4; 6) Leader Allergy Relief, i) 12 Tablets Count Box, NDC 37205-381-53, UPC 0 96295 11227 6; ii) 48 Tablets Count Box, NDC 37205-381-67, UPC 0 96295 11281 8; 7) CVS Allergy relief, 10 Tablets Count Box, NDC 59779-311-52, UPC 0 50428 11366 0; 8) Sunmark allergy relief, i) 10 Tablets Count Box , NDC 49348-634-01, UPC 0 10939 79033 0; ii) 12 Tablets Count Box, NDC 49348-637-02, UPC 0 10939 79333 1; iii) 24 Tablets Count Box, NDC 49348-637-04, UPC 0 10939 79433 8; 9) Rite Aid Loratadine, 30 Tablets Count Box, NDC 11822-0311-3, UPC 0 11822 52712 5; 10) Equaline Allergy Relief, 30 Tablets Count Box, NDC 41163-311-65, UPC 0 41163 46654 8; 11) TopCare Allergy Relief, i) 10 Tablets Count Box, NDC 36800-311-52, UPC 0 36800 08395 0; ii) 12 Tablets Count Box, NDC 36800-824-53, UPC 0 36800 08394 3; iii) 24 Tablets Count Box, NDC 36800-824-62, UPC 0 36800 08396 7; 12) Wal-itin Aller-melts, i) 10 Tablets Count Box, NDC 0363-0311-52, UPC 3 11917 05667 8; ii) 30 Tablets Count Box, NDC 0363-0311-65, UPC 3 11917 10306 8; 13) GoodSense Allergy Relief, 12 Tablets Count Box, NDC 0113-0824-53, UPC 3 70030 14683 3. Recall # D-805-2010
CODE
Lot #’s: 0BE1651, Exp: 05/11; 0BE1653, Exp: 05/11; 0BE1929, Exp: 05/11; 9LE2445, Exp: 05/11; 9LE2603, Exp: 05/11; and 0AE1957, Exp: 05/11
RECALLING FIRM/MANUFACTURER
Recalling Firm:L. Perrigo Co, Allegan, MI, letters dated June 16, 2010.  
Manufacturer: Watson Laboratories, Inc.-Florida, Fort Lauderdale, FL. Firm initiated recall is ongoing.
REASON
Stability Data does not Support Expiration Date: product failed stability test results at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE
67,692 Cartons
DISTRIBUTION
GA, ID, IA, IL, MN, NY, OH, PA, RI and TX
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT   
Source Plasma. Recall # B-2056-10
CODE
Units: FD0500537, FD0502880, FD0503259, FD0509894, FD0515518, FD0516063, FD0517957, FD0518606, FD0522255, FD0523346, FD0523544, FD0524204, FD0524698, FD0525142, FD0525845, FD0526653, FD0526878, FD0527579, FD0527845, FD0528519, FD0528827, FD0529544, FD0529761, FD0530471, FD0530712, FD0531425, FD0531801, FD0532483, FD0532869, FD0537501, FD0537687, FD0538370, FD0543210, FD0546250, FD0546632, FD0547328, FD0547832, FD0548286, FD0548743, FD0549325, FD0549840, FD0550427, FD0551448, FD0551572, FD0552307, FD0553173, FD0553418, FD0554063, FD0554834, FD0555041, FD0559685, FD0560235, FD0560592, FD0561168, FD0561786, FD0562212, FD0562883, FD0563248, FD0564435, FD0564723, FD0565467, FD0565880, FD0566540, FD0567053, FD0567723, FD0567965, FD0568941, FD0569180, FD0570057, FD0571177, FD0571477, FD0572411, FD0572818, FD0573582, FD0573871, FD0574531, FD0576955, FD0577140, FD0579983, FD0580403, FD0581156, FD0581623, FD0582680, FD0583090, FD0584073, FD0584500, FD0585410, FD0586089, FD0586790, FD0587500, FD0588791, FD0589023, FD0590248, FD0590600, FD0591592, FD0592445, FD0593277, FD0593712, FD0594626, FD0595049, FD0596132, FD0596519, FD0597701, FD0598681, FD0599198, FD0600210, FD0600690, FD0601755, FD0602401, FD0603415, FD0603985, FD0605122, FD0608608, FD0609074, FD0609979, FD0610508, FD0611469, FD0612006, FD0612905
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, by facsimile on September 26, 2009 and electronic mail dated January 15, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
119 units
DISTRIBUTION
NY, UK
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2059-10
CODE
53P04562 (triple units), 53P04579 (triple units), 53P04557 (triple units)
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on March 9, 2007 followed by a letter dated March 19, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
D.C., MD
___________________________________
PRODUCT   
Plasma Frozen. Recall # B-2061-10
CODE
Unit: 266832386
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by facsimile on August 12, 2008.
Manufacturer: Blood Systems, Inc., Fort Smith, AR. 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
AR
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2062-10;
2) Plasma Frozen. Recall # B-2063-10
CODE
1) and 2) Unit: 29GS67802
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone and letter on September 14, 2007 and September 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2111-10;
2) Fresh Frozen Plasma. Recall # B-2112-10
CODE
1) Units: 53FL44093; 53GL36993;
2) Unit: 53GL36993
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on October 3, 2007 and by a letter dated October 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
D.C., MD
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2114-10
CODE
Units: 035KC56525, 035KC62585
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone on March 1, 2008 followed by a letter dated March 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, WV, CA
___________________________________
PRODUCT   
1) Cryoprecipitated AHF. Recall # B-2174-10;
2) Red Blood Cells. Recall # B-2175-10;
3) Fresh Frozen Plasma. Recall # B-2176-10;
4) Plasma Cryoprecipitated Reduced. Recall # B-2177-10
CODE
1) Units: 0975643; 0926469; 0921503; 0904536; 0885087;
2) and 3) Unit: 0859227;
4) Units: 0921503; 0975643; 0940018; 0962752; 0926469; 0904536; 0898256; 0885087
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on September 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
MN
___________________________________
PRODUCT   
1) Red Blood Cells. Recall # B-2226-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2227-10
CODE
1) Unit: 004F83282;
2) Unit: 004LF29241
RECALLING FIRM/MANUFACTURER
Arc Blood Services, New England Region, Dedham, MA, by fax and email on April 18, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, MA, NY
___________________________________
PRODUCT   
Source Plasma. Recall # B-2229-10
CODE
Units: 0530663143, 0530662498, 0530662036, 0530661196, 0530665423, 0530665094, 0530664116, 0530663890, 0530661030
RECALLING FIRM/MANUFACTURER
CSL Plasma, Lexington, KY, by email on April 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Germany, Switzerland, IL
___________________________________
PRODUCT   
1) Plasma Frozen within 24 hours (FP24). Recall # B-2230-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2231-10
CODE
1) and 2) Unit: W115910221341
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by fax on May 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2232-10;
2) Recovered Plasma. Recall # B-2233-10
CODE
1) and 2) Units: W087909805613, W08909903614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by fax on April 22, 2010.
Manufacturer: Nebraska Community Blood Bank, Lincoln, NB. Firm initiated recall is complete
REASON
Blood products, collected from a donor who provided a history of hepatitis B, were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, NY, NB
___________________________________
PRODUCT   
Source Plasma. Recall # B-2234-10
CODE
Units: 3890109442, 3890108464, 3890107897
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Lynchburg, VA, by letter on April 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process, for which the donor was not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT   
Source Plasma. Recall # B-2235-10
CODE
Unit: 3980060562
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Little Rock, AR, by fax on January 26, 2010. Firm initiated recall is complete.
REASON
Blood product, that was not quarantined after receiving post donation information concerning high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2236-10;
2) Fresh Frozen Plasma. Recall # B-2237-10
CODE
1) Units: 03GF00179, 03GT75003, 03LL69486;
2) Unit: 03GF00179
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by fax on May 12, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA
___________________________________
PRODUCT   
1) Red Blood Cells Leukocytes Reduced. Recall # B-2244-10
2) Platelets Leukocytes Reduced. Recall # B-2245-10
CODE
1) and 2) Unit: 17GN53783
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on August 15, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN      
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2247-10
CODE
Unit: 17KQ78578
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on September 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN   
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2249-10
CODE
Unit: 2176850
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2250-10
CODE
Unit: W036208320501
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on October 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT   
Red Blood Cells Leukocytes Reduced. Recall # B-2251-10
CODE
Unit: 2165890
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on September 23, 2008. 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
NJ
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT   
Platelets Pheresis Leukocytes Reduced. Recall # B-2060-10
CODE
53P04620 (triple units)
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by a letter dated March 28, 2007. Firm initiated recall is complete. 
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2113-10
CODE
Units: 035KC56525, 035KC62585
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone on March 1, 2008 followed by a letter dated March 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, WV, CA
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2228-10
CODE
Units: 004LF29241, 004F83282
RECALLING FIRM/MANUFACTURER
Arc Blood Services, New England Region, Dedham, MA, by fax and email on April 18, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, MA, NY
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2246-10
CODE
Unit: 17GN53783
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by e-mail on August 20, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT   
Recovered Plasma. Recall # B-2248-10
CODE
Unit: 17KQ78578
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by e-mail on September 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT   
AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system. Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use. Recall # Z-2218-2010
CODE
Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
RECALLING FIRM/MANUFACTURER
AngioScore Inc., Fremont, CA, by letter dated December 4, 2009. Firm initiated recall is ongoing.
REASON
Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
VOLUME OF PRODUCT IN COMMERCE
3,870 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT   
Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only. Usage: Temporary pacing of open hearts: used with External Pacing Generators (EPGs). Recall # Z-2223-2010
CODE
Lot number: 100701
RECALLING FIRM/MANUFACTURER
Remington Medical Inc., Alpharetta, GA, by letter on/about May 19, 2010. Firm initiated recall is ongoing.
REASON
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
VOLUME OF PRODUCT IN COMMERCE
1488 units
DISTRIBUTION
AZ, CA, CO, CT, DE, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TX, TN, TX, VA, WA, WI and Canada
___________________________________
PRODUCT   
medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. Recall # Z-2235-2010
CODE
Lot #MAZL630, Exp. 04/2015
RECALLING FIRM/MANUFACTURER
Medical Components, Inc dba MedComp, Harleysville, PA, by email on July 1, 2010.
REASON
Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
NC, TX and Israel
___________________________________
PRODUCT   
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract. Recall # Z-2236-2010
CODE
Snare Package Lot numbers: 9YK, 9ZK, 01K, 02K, & 03K. Snare Tube Lot Numbers: K9Y10, K9Y16, K9Y18, K9Y19, KDY20, K9Y24, K9Y25, K9Y26, K9Y27, K9Y30,K9Z01, K9Z02, K9Z03, K9Z04, K9Z07, K9Z08, K9Z09, K9Z10, K9Z11, K9Z14,K9Z15, K9Z16, K9Z17, K9Z18, K9Z21, K9Z22, K9Z24, K9Z25, K9Z28, K9Z29, K0105, K0106, K0107, K0108, K0112, K0113, K0114, K0115, K0118, K0119, K0120, K0121, K0122, K0127, K0129, K0202, K0203, K0204, K0205, K0208, K0209, K0210, K0212, K0215, K0216, K0217, K0218, K0222, K0224,K0225, K0226, K0301, K0302, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and K0316
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center Valley, PA, by letter on May 4, 2010.
Manufacturer: Amori Olympus Co., Ltd., Kuroisha-Shi, Aomori-Ken, Japan. Firm initiated recall is ongoing.
REASON
An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare.
VOLUME OF PRODUCT IN COMMERCE
108 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles. Recall # Z-2237-2010
CODE
Serial Number: 400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Neuisys, LLC, Greensboro, NC, by letter on July 21, 2008.
Manufacturer: Philips and Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning,
China. Firm initiated recall is complete.
REASON
The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock. Recall # Z-2294-2010
CODE
Lot numbers: W1515452; W1545383; W1519579, W1524143, W1515454; W1524146, W1519578, W1520649, W1515441; W1515455; 1000093-006 / W1515456; W1560536
RECALLING FIRM/MANUFACTURER
Greatbatch Medical, Minneapolis, MN, by letter dated July 12, 2010. Firm initiated recall is ongoing.
REASON
The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray.
VOLUME OF PRODUCT IN COMMERCE
211 5-pack boxes totaling 1055 individual units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. This is an Export Only test kit that is not marketed in the U.S. Recall # Z-2295-2010
CODE
Lot number 345158910 Exp: 2011/04/21
RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO, by letter dated July 29, 2010. Firm initiated recall is ongoing.
REASON
Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.
VOLUME OF PRODUCT IN COMMERCE
1,297 boxes with 20 cards each (25,940 cards
DISTRIBUTION
Canada
___________________________________
PRODUCT   
V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single Use Only, Size: 3/8, X-Ray Detectable In Holders. There are various uses including as gauze/sponge internal, x-ray detectable and as dissectors. Recall # Z-2296-2010
CODE
Lot number: 3405
RECALLING FIRM/MANUFACTURER
Recalling Firm: He, Inc., Martinez, GA, by letter dated March 1, 2010.
Manufacturer: G3 Medical, Asheville, NC. Firm initiated recall is ongoing.
REASON
Sterile product packaging contains weak seals, which may result in compromised product sterility.
VOLUME OF PRODUCT IN COMMERCE
551 cases of 100 packages per case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
VP 2000 Processor Heated Reagent Basins; automated slide stainer; The basins are sold under the following part numbers: a) list 02J11-013, part number 30-144152 (replacement basins); b) list 02J11-060, part number 30-144100 (as a component of the 100 volt VP 2000 Processor); c) list 02J11-001, part number 30-144101 (as a component of the 117 volt VP 2000 Processor); d) list 02J11-004, part number 30-144102 (as a component of the 230 volt VP 2000 Processor); Designed to automate and standardize FISH slide specimen processing and routine slide staining for the laboratory. Recall # Z-2313-2010
CODE
All basins distributed since September 2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Molecular, Des Plaines, IL, by letters dated July 20, 2010.  
Manufacturer: U.S. Machine and Tool, Round Lake, IL; Pcm, Co., Camden, NJ. Firm initiated recall is ongoing.
REASON
The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.
VOLUME OF PRODUCT IN COMMERCE
219 basins
DISTRIBUTION
Nationwide, Australia, Belgium, France, Germany, India, Italy, Japan, Pakistan, Poland, Russia, Singapore, South Korea, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay
___________________________________
PRODUCT   
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 Hole, Right - 148 MM, REF 71800710, Qty: (1), Sterile R, CE 0086. Adult and pediatric patients, as indicated for pelvic, small, and long bone fracture fixation. Recall # Z-2314-2010
CODE
Lot number: 08GM01779
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Memphis, TN, by letter dated July 20, 2010. Firm initiated recall is ongoing.
REASON
Inner packaging of sterile product was not sealed. Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
China, UK, Italy, Australia, and South Africa
___________________________________
PRODUCT   
1) Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog Number: M00513720. Recall # Z-2316-2010;
 
2) Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal Release (18/23/12/9) Material/UPN/Catalog Number: M00513740. Recall # Z-2317-2010;
 
3) Boston Scientific Ultraflex Uncovered Esophageal Stent System - Proximal Release (18/23/7) Material/UPN/Catalog Number: M00513800. Recall # Z-2318-2010;
 
4) Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/10/7) Material/UPN/Catalog Number: M00513840. Recall # Z-2319-2010;
 
5) Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9) Material/UPN/Catalog Number: M00513850. Recall # Z-2320-2010;
 
6) Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/15/12) Material/UPN/Catalog Number: M00513860. Recall # Z-2321-2010;
 
7) Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200. Recall # Z-2322-2010;
 
8) Boston Scientific Ultraflex Uncovered Large Esophageal Stent System - Distal Release (23/28/12) Material/UPN/Catalog Number: M00514230. Recall # Z-2323-2010;
 
9) Boston Scientific Ultraflex Covered Large Esophageal Stent System - Proximal Release (23/28/12/9) Material/UPN/Catalog Number: M00514250.  Recall # Z-2324-2010;
 
10) Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10/4) Material/UPN/Catalog Number: M00564670. Recall # Z-2325-2010;
 
11) Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/2.5) Material/UPN/Catalog Number: M00564760. Recall # Z-2326-2010;
 
12) Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2.5) Material/UPN/Catalog Number: M00564800. Recall # Z-2327-2010;
 
13) Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4.5) Material/UPN/Catalog Number: M00564840. Recall # Z-2328-2010;
 
14) Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (18/4/2.5) Material/UPN/Catalog Number: MOO564860. Recall # Z-2329-2010;
 
15) Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (20/6/4.5) Material/UPN/Catalog Number: M00564900. Recall # Z-2330-2010;
 
16) Boston Scientific Ultraflex Precision Colonic Stent System Material/UPN/Catalog Number: M00557360. Recall # Z-2331-2010
CODE
1) Lot/Batch Number: 13450513;
2) Lot/Batch Number: 13442098;
3) Lot/Batch Number: 13469828;
4) Lot/Batch Number: 13441743;
5) Lot/Batch Number: 13435072;
6) Lot/Batch Number: 13436212;
7) Lot/Batch Number: 13436624;
8) Lot/Batch Number: 13419034;
9) Lot/Batch Number: 13453530;
10) Lot/Batch Number: 13485289;
11) Lot/Batch Number: 13432642;
12) Lot/Batch Number: 13473372;
13) Lot/Batch Number: 13439023;
14) Lot/Batch Number: 13433240;
15) Lot/Batch Number: 13432371, 13436055;
16) Lot/Batch Number: 13432574
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Corp., Marlborough, MA, by letters dated July 15, 2010.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing
REASON
Units have excessive fraying of the deployment suture thread; as a result, these devices may experience a suture break during deployment.
VOLUME OF PRODUCT IN COMMERCE
121 units
DISTRIBUTION
Nationwide, Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugal, Spain, and Sweden
___________________________________
PRODUCT   
Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Intended for temporary fixation, correction, or stabilization of the right femur. Recall # Z-2340-2010
CODE
Lot code K248963; Expiration: 8/14/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm:Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on July 23, 2010 and July 26, 2010.
Manufacturer: Stryker Worldwide, Kiel, Germany. Firm initiated recall is ongoing.
REASON
The nail has no thread for the set screw hindering insertion.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NJ, NY, DE, IN, WI, IL, PA and NM
___________________________________
PRODUCT   
1) CELL-DYN 3200 CS and SL, Hematology Analyzer. Waste Reservoir Assembly Part number 8921174802. Recall # Z-2350-2010
 
2) CELL-DYN 3700 CS and SL, Hematology Analyzer. Waste Reservoir Assembly Part number 8921174802. Recall # Z-2351-201;
 
3) CELL-DYN Ruby, Hematology Analyzer. Waste Reservoir Assembly Part number 8921174802. Recall # Z-2352-2010;
 
4) CELL-DYN Sapphire, Hematology Analyzer. Waste Reservoir Assembly Part number 8921174802. Recall # Z-2353-2010
CODE
1) Reservoir Date Codes Dec 17 2009 to March 17, 2010. Serial numbers-- CS: 04H59-01/30664AH, 4H59-03/30276AH96, 30671AH96, 30673AH96. SL: 04H60-01, 62794AF-62799AF, 62144AF, 62772AF, 62073AF, 61628AF, 61376AF;
 
2) Reservoir Date Codes Dec 17 2009 to March 17, 2010. Serial numbers-- CS: 02H30-01/20478AN, 20479AN SL: 02H31-01/22470AK, 21690AK, 22062AK, 21699AK, 20756AK, 22459AK, 21302AK, 21601AK, 22753AK;
 
3) Reservoir Date Codes Dec 17 2009 to March 17, 2010. Serial numbers-- 08H67-01/35286BG-35318BG, 34891BG, 34641BG, 34408BG, 34890BG, 34021BG;
 
4) Reservoir Date Codes Dec 17 2009 to March 17, 2010. Serial numbers-- 08H00-01/42297AZ, 42909AZ, 42080AZ, 42410AZ
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on April 16/2010. Firm initiated recall is complete.
REASON
Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
CA, CT, ID, IN, MA and Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay
___________________________________
PRODUCT   
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-2355-2010
CODE
Lot Numbers: 917073, 918433 & 916271
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated June 29, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.
VOLUME OF PRODUCT IN COMMERCE
1,071
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT   
1) Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile. Recall # Z-2356-2010;
 
2) Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF 540-428, Rx, Sterile. Recall # Z-2357-2010;
 
3) Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile. Recall # Z-2358-2010;
 
4) Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF 540-482, Rx, Sterile.Recall # Z-2359-2010;
 
5) Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, and Sterile.Recall # Z-2360-2010;
 
6) 21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile. Recall # Z-2361-2010;
 
7) 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, and Sterile.
Recall # Z-2362-2010;
 
8) 21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, and Sterile.  Recall # Z-2363-2010;
 
9) 22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, and Sterile. Recall # Z-2364-2010;
 
10) 24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile. Recall # Z-2365-2010;
 
11) 18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile. Recall # Z-2366-2010;
 
12) 18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile. Recall # Z-2367-2010;
 
13) 18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile. Recall # Z-2368-2010;
 
14) 17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile. Recall # Z-2369-2010;
 
15) 17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile. Recall # Z-2370-2010;
 
16) 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile. Recall # Z-2371-2010;
 
17) 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-050, Rx, Sterile. Recall # Z-2372-2010;
 
18) 17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-090, Rx, Sterile. Recall # Z-2373-2010;
 
19) 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-150, Rx, Sterile. Recall # Z-2374-2010;
 
20) 21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile. Recall # Z-2375-2010;
 
21) 21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx, Sterile. Recall # Z-2376-2010;
 
22) 22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx, Sterile. Recall # Z-2377-2010;
 
23) 22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile. Recall # Z-2378-2010;
 
24) 24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx, Sterile. Recall # Z-2379-2010
CODE
1) Lots: 2005060903, 2005070401;
 
2) Lots: 2009040701, 2009042102;
 
3) Lots: 2009042103;
 
4) Lots: 2009042103;
 
5) Lots: 0507702223, 0524301373 and 0603705603;
 
6) Lots: 20130202, 20130415, 20140421, 20140609, 5046231227, 5076244238, 5122261790, 5143269915, 5167280677, 5187287779, 5206296117, 5223302038, 5269320118, 5283325629, 5306337317, 5332345739, 5339349276, 6025365183, 6041378163, 6074391286, 6088396277, 6124416923, 6135420668, 6150423728, 6172437516, 6187443411, 6201449651, 6226460917, 6250470746, 6269479417, 6286486660, 6321504502, 6335510754, 7010527909, 7033539866, 7068555924, 7085564091, 7106573430, 7134586527, 7180607419, 7192611056, 7240632667, 7333675532, 7355686304, 8039708245, 8052714217, 8070721005, 8105738000, 8148758189, 8150759733, 8172770405, 8191778149, 8225794524, 8231796797, 8276817903, 8289824215, 8301830046, 8330847601, 8357862273 and 9009870299;
 
7) Lots: 20130217, 20140414, 20140507, 20140527, 20140528, 20140610, 20140716, 5046231300, 5101251562, 5122261791, 5133266600, 5153274678, 5157276042, 5187287783, 5200294494, 5208298022, 5241310863, 5269320112, 5283325624, 5291331195, 5306337318, 5319341187, 5332345743, 5342350291, 6004356829, 6004360560, 6037374453, 6054381257, 6061387795, 6073391292, 6088396287, 6090400765, 6107408674, 6121415236, 6135420667, 6150423848, 6158429977, 6163432688, 6172437498, 6174438863, 6186443028, 6221458770, 6255473157, 6283486655, 6313500842, 6321504503, 6342514077, 6353518040, 7005525171, 7026536490, 7037541403, 7054549741, 7068555927, 7074559182, 7107573680, 7142589688, 7176604912, 7184608177, 7192611054, 7263643184, 7290656233, 7330674022, 7330674024, 7355686009, 8022698982, 8039708180 8045710627, 8052714216, 8070721966, 8105737996, 8148758188, 8150759732, 8176772079, 8191778150, 8226795127, 8277818561, 8302830726, 9009870015 and 9029881744;
 
8) Lots: 5070237478, 5101251566, 5126264328, 5167280678, 5187287785, 5259317857, 5283325626, 5342350292, 6054381263, 6088396285, 6160431974, 6172437501, 6264477580, 6335510755, 7005525170, 7012528659, 7026536489, 7033539877, 7059551767, 7061552956 7074559142, 7099569799, 7107574179, 7165600823, 7214621893, 7234630667, 7262643183, 7333675530, 7333675534, 8002688356, 8105738001, 8225794525, 8231797179, 8232797381 and 9009870341;
 
9) Lots: 0712528672, 20130203, 20140416, 20140608, 20140715, 5024221299, 5045228649, 5053234209, 5088247906, 5122261789, 5132266598, 5146272239, 5167280675, 5187287781, 5192290486, 5206296116, 5217302034, 5220302789, 5223304300, 5241310864, 5269320113, 5283325627, 5306337319, 5332345740, 5342350289, 5353356034, 6004360561, 6030372974, 6054381259, 6069391284, 6090400764, 6116413482, 6129418991, 6135420666, 6152427566, 6163432689, 6173438178, 6181441544, 6205450444, 6229462810, 6250470745, 6268479131, 6314501888, 6355519500, 7037541404, 7061552958, 7074559123, 7109575212, 7143589689, 7214621894, 7239632668, 8023698983, 8039708241, 8066720745, 8105737999, 8148758187, 8177772498, 8231796752, 8261810747, 8277818564, 8302830742 and 9029881729;
 
10) 5024221300, 5066234842, 5098251564, 5108256483, 5122261793, 5241310866, 5332345742, 6025365198, 6054381265, 6124416924, 6135420665, 6179440931, 6198447630, 6263476609, 6353518297, 7037541401, 7061552957, 7109575215, 7263643185, 7333675531, 8002688741, 8070721007, 8203783830 and 8277818567
 
11) Lots: 20130218, 20140521, 20140617, 20140618, 20140622, 20140714, 5076244239, 5125262589, 5133266601, 5147272238, 5167280674, 5178285221, 5196293132, 5206296118, 5223304302, 5259318011, 5283325622, 5305337320, 5325344646, 5339349275, 6018365171, 6034385142, 6037374454, 6041376932, 6054381264, 6073391288, 6090400763, 6103407346, 6116413483, 6129418990, 6160431975, 6172437499, 6181441545, 6191444279, 6200449171, 6214455260, 6223459782, 6250470747, 6272481780, 6289489210, 7005525175, 7026536491, 7054549735, 7059551768, 7068555925, 7088565466, 7122581136, 7134586529, 7165600824, 7197613215, 7242634654, 7292657557, 7337676788, 7351683601, 8022698984, 8039708181, 8056715165, 8070721971, 8085729473, 8121746169, 8156761800, 8177772495 and 8231796760;
 
12) Lots: 0887730428, 20130205, 20130421, 20130422, 5125262586, 5146272236, 5167280672, 5187287778, 5201294495, 5223302036, 5259318014, 5283325623, 5305337322, 5308337696, 5336344652, 6018365172, 6034385141, 6073391289, 6090400762, 6107408673, 6124416925, 6152427564, 6171434889, 6173438179, 6181440288, 6187443412, 6200449170, 6227460910, 6268479135, 6286486661, 6342514078, 7012528660, 7044544767, 7059551766, 7065554362, 7088565465, 7107573688, 7134586531, 7165600825, 7197613217, 7261642324, 7262643186, 7289656229, 7316668203, 7337676790, 7338677399, 7348682596, 8008691271, 8022698985, 8056715161, 8070721969, 8121746168, 8203783647, 8277818562 and 8302830743;
 
13) Lots: 0870721970, 5336344653, 6054381260, 6090400766, 6166434891, 6223459783, 6283485237, 7012528657, 7044544777, 7074559129, 7134586532, 7180607467, 7198611057, 7240632669, 7242634656, 7262643187, 7333671815, 8002688547, 8056715164 and 8121746166;
 
14) Lots: 20090219, 20090421, 20090609, 20100716, 8231797111, 8294826537 and 8302830741;
 
15) Lots: 20090220, 20100717, 8203783650, 8231796755 and 8294826536;
 
16) Lots: 20090608, 8231797109 and 8294826538;
 
17) Lots: 0000807196, 0000808106, 0000809147, 0000809329, 0000811192 and 0000901263;
 
18) Lots: 0000806234, 0000807197, 0000808107, 0000809148, 0000809330, 0000811193 and 00081193;
 
19) Lots: 0000805216, 0000807198, 0000809149, 0000809331 and 0000811194;
 
20) Lots: 20130220, 20130527, 20130610, 5066234837, 5122261794, 5206296119, 5325344651, 6088396272, 6129418992, 6160431977, 6174438865, 6194446416, 6226460919, 6235463674, 6268479139, 7059551764, 7074559184, 7107573676, 7143590429, 7176604915, 7192611055, 7240632670, 8105738005, 8177772497, 8203783809, 8240801366, 8277818568 and 8302830746;
 
21) Lots: 6171434890, 7088565451, 7109575216 and 8203783833;
 
22) Lots: 20130402, 20130417, 5157276046, 5241310865, 5322341821, 6025365199, 6054381261, 6088396279, 6103407344, 6140423727, 6160431976, 6173438180, 6192445451, 6236465683, 6261475102, 6289489211 7054549736, 7066554360, 7081561706, 7113575378, 7143590434, 7176604919, 7192611077, 7240632671, 7263643188, 8002688742, 8056715166, 8105738336, 8177772499, 8204783981, 8231797107, 8277818566 and 8302830744;
 
23) Lots: 5024221297, 5045228650, 5098251563, 5122261792, 5259318012, 5342350293, 6073391308, 6129416926, 6163432690, 6191444280, 6226460920, 6255473199, 7033539875, 7066554296, 7107573689, 7143590438, 7176604921, 7205616427, 7240632672, 8002688743 8100736250, 8150759626, 8177772496, 8277818565 and 8302830745;
 
24) Lots: 5024221298, 5066234835, 5167280676, 5269320117, 6058381262, 6088396282, 6171435393, 7054549744, 7109575213 and 8203783829
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter on February 2, 2010.
Manufacturers: Imed Ireland Limited, Donegal, Ireland; Integra Life Sciences Corp., Salt Lake City, UT; Te Me Na Sas, Carrieres Sur Seine, France. Firm initiated recall is ongoing.
REASON
Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
VOLUME OF PRODUCT IN COMMERCE
18,826 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids. Model numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153, 91000154, 91000156. Recall # Z-2380-2010
CODE
Master lot numbers on shipping cartons: oo1K through 365K, 001P through 365P, 001S through 365S. Shelf carton and unit level lot numbers" 0901xxxx through 1001xxxx
RECALLING FIRM/MANUFACTURER
Vital Signs Inc., Totowa, NJ, by letter, dated July 15, 2010. Firm initiated recall is ongoing.
REASON
The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings.
VOLUME OF PRODUCT IN COMMERCE
385, 820 Domestic - 20,766 International
DISTRIBUTION
Nationwide and Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam
           
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT   
1) COULTER LH 500 Series System. Recall # Z-2337-2010;
 
2) Unicel DxH 800 Coulter Cellular Analysis System. Recall # Z-2338-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters beginning the week of February 15, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is complete.
REASON
The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #, @, [, \ , ], `,{, |, } or ~ are substituted or omitted in other languages. The issue affects the LH500 and DxH 800. Issue 2: Independent of language, the DxH 800 omits the characters *?” when used as part of the selected demographics including Speciman ID and Patient ID. Issue 3: In the DxH 800, space (s) used as leading character (s) in a Patient or Specimen ID, can cause random insertion of extra character (s) within that identifier. Issue 4: The LH500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner. This is independent of language configuration on system.
VOLUME OF PRODUCT IN COMMERCE
1,576 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT   
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free. Part number 262261. Recall # Z-2354-2010
CODE
Lot number 1925391
RECALLING FIRM/MANUFACTURER
Dental EZ Stardental Division, Lancaster, PA, by letter on August 11, 2010. Firm initiated recall is ongoing.
REASON
The housing of 5K motor is labeled as a 20K motor.
VOLUME OF PRODUCT IN COMMERCE
41 motors
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR SEPTEMBER 8, 2010
 
 
 
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