Safety
Enforcement Report for November 24, 2010
November 24, 2010 10-46
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Simply Fresh Fruit, Apple Slices, Net Wt 2 oz (57G), Keep Refrigerated between 34 – 38 F. UPC 0 77554 00227 9. Ingredients: Fresh Apples, Calcium Ascorbate (a blend of Calcium and Vitamin C to maintain freshness and color). Product of USA. Recall # F-0176-2011
CODE
Use By Date: 11/09/10
RECALLING FIRM/MANUFACTURER
Marjon Specialty Foods, Inc., Plant City, FL, by telephone on October 21, 2010 with a follow-up e-mail. Firm initiated recall is ongoing.
REASON
Product tested positive for Listeria.
VOLUME OF PRODUCT IN COMMERCE
280 cases (100 2 oz bags
DISTRIBUTION
FL
___________________________________
PRODUCT
Mung bean sprouts in clear 9 oz. and clear 5 lb. bags. 9 oz. bag labeled Shanghai Bean Sprouts No Preservatives All Natural Grown in Oregon Net Wt. 9 oz Country of Origin - China Sprouted, Harvested and Packaged in Oregon, UPC 0O54663200802 5 lb bag labeled: Grown in Pure Well Water NO Preservatives Added Net Wt. 80 oz. (5 lbs.) Country of Origin (China) Sprouted, Harvested & Packed (In Oregon) UPC054663100805. Recall # F-0185-2011
CODE
291004, 292004 First 3 digits represent Julian date. Some product also contained a 7 day sell by date of 10 25 2010 and 10 26 2010.
RECALLING FIRM/MANUFACTURER
Shanghai Co Inc., Portland, OR, by telephone and e-mail on October 20, 2010. FDA initiated recall is complete.
REASON
Product is potentially contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
330/5 lb. bags, plus 1776/9 oz. bags
DISTRIBUTION
OR
___________________________________
PRODUCT
Nestle RAISNETS Fun Size Bags, 10 oz, 24 Bags/case, Production Code: 02015748, UPC number: 2800010255. Recall # F-0186-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA, Glendale, CA, by press release on October 22, 2010.
Manufacturer: Nestlé’s USA, Inc., Burlington, WI. Firm initiated recall is ongoing.
REASON
The product may contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
1,063 cases
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Berry Full Mix in 8 oz. and 13 oz. plastic trays and bulk 20 lb bag inside a brown box. UPC 94776 03475, 94776 08172 and 9477603403. Recall # F-0172-2011;
2) Chunks 15 oz. in plastic trays, 12 per case, UPC 6020812449. Recall # F-0173-2011;
3) California trail mix no salt, 13 oz in plastic trays and bulk 20 lb bag inside a brown box. UPC 9477608168, 9477603399. Recall # F-0174-2011;
4) Mixed fruit imperials in bulk 24 lb bag inside a brown box. UPC 9477603400. Recall # F-0175-2011;
CODE
Date range from 1/1/2009 through 8/25/2010
RECALLING FIRM/MANUFACTURER
Lipari Foods, Inc., Warren, MI, by letter on August 25, 2010. Firm initiated recall is ongoing.
REASON
Products contain FD & C yellow # 5 that is not declared in the package labels.
VOLUME OF PRODUCT IN COMMERCE
29,618 all products
DISTRIBUTION
MI, IL, IN, OH, WV, PA, KY, WI, VA, TN
___________________________________
PRODUCT
1) Pediatric Electrolyte Oral Solution Bubble Gum: 1/2 Liter 17 oz 8 Pack, Aaron Brands Item Number: FP-01-178-33201 UPC Code: 15256-3320, Aaron Brands Item Number: FP-01-338-33210 UPC Code: 15256-33210; 1 Liter 33 oz 8 Pack, CVS Pharmacy Item Number: FP-39-338-04220, UPC Code: 50428-04220, Kinray Item Number: FP-70-338-33210 UPC Code: 15256-33210, Watson/Rugby Item Number: FP-87-338-93686 UPC Code: 0536-0936-86. Recall # F-0177-2011;
2) Pediatric Electrolyte Oral Solution Apple: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Number: FP-01-178-33221 UPC Code 15256-33221; FP-01-338-33230 UPC Codes: 15256-33230; Discount Drug Mart Item Number: FP-34-178-12694 UPC Code: 93351-12694; Kinray Item Number: FP-70-338-33230 UPC Code: 5256-33230; 1 Liter 33 oz 8 Pack: CVS Pharmacy Item Number: FP-39-338-01768 UPC Code: 50428-01768, Midway/Repone Item Number: FP-88-338-00046 UPC Code: 94162-00046. Recall # F-0178-2011;
3) Pediatric Electrolyte Oral Solution Cherry: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Number: FP-01-338-33240 UPC Codes: 15256-33240. Recall # F-0179-2011;
4) Pediatric Electrolyte Oral Solution Grape: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Numbers: FP-01-178-33211, FP-01-338-33220 UPC Codes: 15256-33211 15256-33220; Discount Drug Mart Item Numbers: FP-34-338-12666, FP-34-178-12695 UPC Codes: 93351-12666, 93351-12965; Dollar Tree Item Number: FP-30-178-33211 UPC Codes: 15256-33211; Kinray Item Number: FP-70-338-33220 UPC Code 15256-33220; Premier Value Item Number: FP-68-338-01117 UPC Code: 40986-01117 1 LITER 33 OZ 8 PACK CVS Pharmacy Item Number: FP-39-338-37896 UPC Code: 50428-37896; Midway/Repone Item Number: FP-88-338-00042 UPC Code: 94162-00042; Nash Finch/OF Item Number: FP-71-338-43174 UPC Code: 70253-43174; Quality Choice Item Number: FP-17-338-95710 UPC Code: 35515-95710; Watson/Rugby Item Number: FP-87-338-38586 UPC Code: 0536-1385-86; Select Brand Item Number: FP-47-338-00788 UPC Code: 15127-00788. Recall # F-0180-2011;
5) Pediatric Electrolyte Oral Solution Fruit: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Numbers: FP-01-178-33241, FP-01-338-33250 UPC Codes: 15256-33241, 15256-33250; Discount Drug Mart Item Numbers: FP-34-338-12664, FP-34-178-12696 UPC Codes: 93351-12664 93351-12969 Dollar Tree Item Number: FP-30-178-33241 UPC Codes: 15256-33241; Kinray Item Number: FP-70-338-33250 UPC Code: 15256-33250; Premier Value Item Number: FP-68-338-01116 UPC Code: 40986-01116 1 LITER 33 OZ 8 PACK CVS Pharmacy Item Number: FP-39-338-58530 UPC Code: 50428-58530; Midway/Repone Item Number: FP-88-338-00040 UPC Code: 94162-00040; Nash Finch/Our Family Item Number: FP-71-338-43179 UPC Code: 70253-43179; Quality Choice Item Number: FP-17-338-97606 UPC Code: 35515-37606; Watson/Rugby Item Number: FP-87-338-93586 UPC Code: 0536-0935-86; Select Brand Item Number: FP-47-338-00532 UPC Code: 15127-00532. Recall # F-0181-2011;
6) Pediatric Electrolyte Oral Solution Pineapple: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Numbers: FP-01-178-33261, FP-01-338-33270 UPC Codes: 15256-33261, 15256-33270 1 LITER 33 OZ 8 PACK CVS Pharmacy Item Number: FP-39-338-11112 UPC Code: 50428-11112. Recall # F-0182-2011;
7) Pediatric Electrolyte Oral Solution Mango: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Numbers: FP-01-178-33251, FP-01-338-33260 UPC Codes: 15256-3325, 15256-33260 1 Liter 33 oz 8 Pack Kroger Item Number: FP-78-338-35073 UPC Code: 41260-35073. Recall # F-0183-2011;
8) Pediatric Electrolyte Oral Solution Unflavored: 1/2 Liter 17 oz 8 Pack Aaron Brands Item Numbers: FP-01-338-33280, FP-01-178-33271 UPC Codes: 15256-33280, 15256-33271; Premier Value Item Number: FP-68-338-01118 UPC Code: 40986-01118 1 LITER 33 oz 8 Pack CVS Pharmacy Item Number: FP-39-338-91266 UPC Code: 50428-91266; Discount Drug Mart Item Number: FP-34-338-12665 UPC Code 93351-12665; Kinray Item Number: FP-70-338-33280 UPC Code 15256-33280; Nash Finch/Our Family Item Number: FP-71-338-43178 UPC Code 70253-43176; Quality Choice Item Number: FP-17-338-98261 UPC Code: 35515-98261; Watson/Rugby Item Number: FP-87-338-00486 UPC Code: 0536-0004-86; Select Brand Item Number: FP-47-338-00533 UPC Code: 15127-00533. Recall # F-0184-2011
CODE
1) Lot Numbers: 45333, 45341, 45447, 45448, 45451, 46241, 46251, 46543, 46574, 46954, 47365, 47366, 47367, 47368, 47369, 47679, 47913;
2) Lot Numbers: 45444, 46542, 45344, 45019, 46490, 45023, 45442, 46260, 46580, 46953, 46245, 46973, 45533, 46534, 46594, 46857, 47404, 47419;
3) Lot Numbers: 45796;
4) Lot Numbers: 45334, 45452, 47384, 47914, 45342, 46270, 47313, 47407, 45295, 45775, 47632, 47766, 45602, 45020, 45039, 46881, 45026, 45449, 46258, 46895, 46243, 46876, 47556, 45030, 46257, 47784, 45134, 47406, 45848, 46269, 46239, 47352, 47353, 47354, 45532, 46533, 47086, 47403, 47418, 47983;
5) Lot Numbers: 45337, 45453, 46773, 47385, 47777, 45345, 47477, 45018, 45352, 47298, 47619, 47710, 45601, 45777, 45021, 45038, 46567, 45027, 45454, 45456, 45457, 45857, 46603, 46873, 45455, 45359, 45743, 46248, 45029, 46553, 48234, 46246, 45421, 45742, 47402, 45850, 46679, 46871, 46240, 47355, 47356, 47357, 47358, 47359, 47360, 47361, 47362, 47363, 47364, 47917, 47918, 48010, 48011, 48020, 46762, 45531, 45744, 46531, 46532, 46664, 46677, 47405, 47478, 47982, 48296;
6) Lot Numbers: 45339, 45347, 46606, 45025, 45450, 45745, 45858, 47948;
7) Lot Numbers: 45338, 45346, 47145, 47375;
8) Lot Numbers: 45340, 45441, 46186, 47680, 45348, 46936, 45353, 46891, 45022, 46170, 45445, 45446, 45855, 45914, 45927, 46242, 46249, 45031, 45881, 46866, 45422, 47047, 45849, 46850, 47409, 47408, 46238, 46261
RECALLING FIRM/MANUFACTURER
Aaron Industries, Inc., Lynwood, CA, by letter on May 21, 2010. Firm initiated recall is ongoing.
REASON
Potential leakage of the bottles.
VOLUME OF PRODUCT IN COMMERCE
928,520 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Tamoxifen Citrate Tablets, USP, 10 mg, 180 count bottle, Rx only, NDC 0093-0784-86. Recall # D-082-2011
CODE
Lot number: 394204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated September 22, 2010.
Manufacturer: Teva Pharmaceutical Industries, Ltd, Kfar Sava, Israel. Firm initiated recall is ongoing.
REASON
Tablet Thickness: Some tablets may not meet weight requirements.
VOLUME OF PRODUCT IN COMMERCE
4,124 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Steril-Eyes (purified water) Eye Wash, a) 1.0 Fl oz. (30 mL) single use bottle (NDC 59898-100-28); b) 4 Fl oz. (120 mL) single use bottle (NDC 59898-100-12). Recall # D-083-2011
CODE
a) W09801SE, W09802SE, W09803SE, W09804SE; EXP: 01/12 b) no lot#, EXP: 11/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Water-Jel Technologies, LLC, Carlstadt, NJ, by telephone on September 10, 2010 and by letter dated October 27, 2010.
Manufacturer: Stericon Pharma Pvt. Ltd., Bangalore, Karnataka, India. Firm initiated recall is ongoing.
REASON
cGMP Deviations: for significant violations of Current Good Manufacturing Practices (CGMP) regulations for Finished Pharmaceuticals, the firm cannot assure sterility of their finished sterile products.
VOLUME OF PRODUCT IN COMMERCE
168,533 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PredniSONE Tablets, USP, 10 mg, 21 tablets, Rx only, NDC 0603-5338-15. Recall # D-084-2011
CODE
Lot number: L091D10A, exp. 04/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by letter dated July 15, 2010.
Manufacturer: Qualitest Pharmaceuticals, Charlotte, NC;
Vintage Pharmaceuticals, LLC DBA Qualitest Pharmaceuticals, Huntsville, AL. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug): a tablet was found to be 129.5% of the label claim.
VOLUME OF PRODUCT IN COMMERCE
36,168 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0002-11
CODE
Unit: 09GX63856
RECALLING FIRM/MANUFACTURER
The American National Red Cross Blood Services, Omaha, NE, by letter and facsimile on October 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE, CA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0058-11
CODE
Unit: 7292475
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by fax on June 29, 2007.
Manufacturer: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
1) Platelets. Recall # B-0059-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0060-11
CODE
1) Unit: 4214384;
2) Units: 4409008, 4214384
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by fax on July 2 and 12, 2007 and October 13, 2007.
Manufacturer: Oklahoma Blood Institute, Lawton OK. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, NY, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0063-11
CODE
Units: 3502660, 3224919
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax on March 16, 2005 and by letter on October 20, 27, 2006. 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
ID, FL, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0066-11
CODE
Unit: 4990290C
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on June 14, 2005 and by follow-up letter on July 12, 2005. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Platelets. Recall # B-0067-11;
2) Fresh Frozen Plasma. Recall # B-0068-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0069-11
CODE
1) and 2) Unit: 5205888;
3) Units: 7203151, 7101976, 5491202, 5433339, 5205888
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on June 15, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OK, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0071-11
CODE
Units: 4968619, 5665882
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on April 26, 2007 and May 07, 2007.
Manufacturer: Oklahoma Blood Institute, North Oklahoma City Donor Center – OBI, Oklahoma City, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0131-11
CODE
Units: C27987 (part C and D)
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on April 29, 2005. 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
NY
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0132-11
CODE
Unit: A164180
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on June 28, 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
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0133-11
CODE
Units: Z123621, Z124890
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on July 5, 2005.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. 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
WA, FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0134-11;
2) Platelets. Recall # B-0135-11
CODE
1) and 2) Unit: R302492
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on July 26, 2005.
Manufacturer: Puget Sound Blood Center and Program, Everett, WA. 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
WA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0136-11;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0137-11
CODE
1) and 2) Unit: N149468
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on July 20, 2005.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. 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
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0139-11
CODE
Units: 0550428014, 0550414921, 15227560, 15216960, 15204493, 0550433466, 0550432298, 0550430888
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Gresham, OR, by fax on July 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
IN, IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0218-11
CODE
Unit: 4801691
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by telephone and facsimile on April 11, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0223-11
CODE
Unit: W068508356611 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on March 27, 2008. Firm initiated recall is complete.
REASON
Blood products, which had a low hemoglobin level, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-0236-11
CODE
Units: TA2138242, TA2138547, TA2139135, TA2139369, TA2140208, TA2140517, TA2141832, TA2142129, TA2142680, TA2142993, TA2144343, TA2145207, TA2145916, TA2147185, TA2147582, TA2148034, TA2148427, TA2148894, TA2149292, TA2149728, TA2150257, TA2150718, TA2151122, TA2151617, TA2152019, TA2152488, TA2152838, TA2153361, TA2153612, TA2154321, TA2154433, TA2155147, TA2155294, TA2156307, TA2156716, TA2163512, TA2164121, TA2164795, TA2170917, TA2171206, TA2172056, TA2173270, TA2173537, TA2174092
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by letter on July 21, 2008 and July 24, 2008.
Manufacturer: DCI Biologicals Texarkana LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
NC and England
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0249-11
CODE
Unit: W141608391534
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by facsimile on March 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBU1TION
WA
___________________________________
PRODUCT
1) Whole Blood CPDA-1. Recall # B-0261-11;
2) Cryoprecipitated AHF. Recall # B-0262-11;
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0263-11;
4) Red Blood Cells. Recall # B-0264-11;
5) Platelets. Recall # B-0265-11;
6) Fresh Frozen Plasma. Recall # B-0266-11;
7) Red Blood Cells Leukocytes Reduced. Recall # B-0267-11;
8) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0268-11;
9) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0269-11;
10) Platelets Pheresis Leukocytes Reduced. Recall # B-0270- 11
CODE
1) Unit: LE63175;
2) Unit: G27175;
3) Unit: LE83517 (Bags 1 & 2);
4) G09815, G30579, KP35367, S29650, W31269, G20645, G27175, G33744, G34451, G35246, G36087, G37704, LE70240, LQ61552, G26125, GH97741, G15428, G16308, G18612, G21697, GM08206, G25130, FM84020, GQ84913, N85344, G13817, G36928, KP36566, GQ83803, GQ86260, G12517, G28454, G29611, G10521;
5) Units: G30579, KP35367, S29650, G20645, G26125, G27175, FM85531, G33744, G34451, G37704, N81098, LQ61552, G16308, G18612, G21697, GM08206, G25130, G29611, FM84020, LE63175, GQ84913, LE92018, G28454;
6) Units: S29650, G33744, LE70240, N81098, LE99059, G26125, G16308, G18612, G20645, G25130, LE96713, LE92018, G12517, G28454, G29611, LE81563;
7) Units: KP30260, FM85531, N81098, LE99059, LE96713, KP38619, LE92018, LG96540, LE81563;
8) Units: GQ87887, GQ87621;
9) Unit: LE77749;
10) Units: GQ87621, GQ87826, GQ88372
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated August 11, 2006 and April 9, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who tested reactive for the antibody to hepatitis B core antigen (anti-HBc) on two previous occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
92 units
DISTRIBUTION
TN, AR, FL, AZ, MI, PA, MO
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0273-11;
2) Plasma Frozen. Recall # B-0274-11
CODE
1) Units: 020FE02040, 020FJ08208;
2) Unit: 020FJ08208
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by telephone or electronic notification on September 5, 2006.
Manufacturer: Lewis and Clark Region-Montana, Great Falls, MT. 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
MT
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0277-11;
2) Recovered Plasma. Recall # B-0278-11
CODE
1) and 2) Unit: 2702120
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on July 18, 2006 and August 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, NJ
____________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0305-11
2) Recovered Plasma. Recall # B-0306-11
CODE
1) and 2) Unit: 21LH27482
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone and facsimile on March 8, 2006 and by letter dated March 9, 2006. 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
2 units
DISTRIBUTION
IN, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0307-11
CODE
Unit: 020GH36645
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by facsimile on February 24, 2006.
Manufacturer: American National Red Cross, Great Falls, MT. 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
ID
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0311-11
CODE
Unit: 7228816
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated March 9, 2006. 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
OR
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0312-11;
2) Red Blood Cells. Recall # B-0313-11;
3) Platelets. Recall # B-0314-11;
4) Fresh Frozen Plasma. Recall # B-0315-11;
5) Recovered Plasma. Recall # B-0316-11
CODE
1) Unit: 7028806 (2 units);
2) Units: 6043111, 7027228, 6045160;
3) Unit: 6043111;
4) Unit: 7027228;
5) Unit: 6045160
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Anchorage, AK, by letter dated January 10, 2006 January 12, 2006 or January 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AK, MI, FL, NJ
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0317-11
CODE
Unit: 7124617
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated October 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0351-11
CODE
Unit: G22210
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter on April 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0001-11
CODE
Unit: 09GX63856
RECALLING FIRM/MANUFACTURER
The American National Red Cross Blood Services, Omaha, NE, by letter and facsimile on October 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE, CA
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0061-11
CODE
Unit: 4409008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by fax on July 2 and 12, 2007 and October 13, 2007.
Manufacturer: Oklahoma Blood Institute, Lawton OK. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, NY, FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0062-11
CODE
Units: 3024660, 3034493
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax on January 3, 2005 and by follow-up letter on January 6, 2005. Firm initiated recall is complete.
REASON
Blood products, which reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0064-11
CODE
Units: 3502660, 3224919
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by fax on March 16, 2005 and by letter on October 20, 27, 2006. 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
ID, FL, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0070-11
CODE
Unit: E302717
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by fax on July 24, 2006. 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
WA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0126-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0127-11;
3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0128-11;
4) Red blood Cells Leukocytes Reduced Irradiated. Recall # B-0129-11;
5) Platelets Pheresis Leukocytes Reduced. Recall # B-0130-11
CODE
1) Units: N15939, T62688, G27470, N15907, G27480, Y07452, E09128, T62710, G27486, G27490, G27493, G27496, G27499, T62686, T62703, T62704, Y07458, Y07478;
2) Units: T62690, N15914;
4) Units: N15934, E09134, T62692, G27461, G27466, E09131, T62697;
3) Units: C31444C, C31448C, C31441C, C31441D, C70705, C70706C, C70706D, C31448D, C31453C, C31453D, C70708C, C70708D, C70709C, C70709D;
5) Units: C31442D, C31446C, C31442C, C31447C, C31447D, C31449C, C31449D, C31450C, C31450D, C31451C, C31451D, C31454C, C31452C, C31452D
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma WA, by telephone on May 11, 2006. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DIST, RIBUTION
WA, TN, NY, PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0196-11
CODE
Unit: W141607194835
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on July 25, 2007.
Manufacturer: Puget Sound Blood Center, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0197-11
CODE
Units: 035Y85105; 035Y85107
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Roanoke, VA, by telephone on August 3, 2007 and by letter on August 8, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0217-11
CODE
Units: 4282605 (2 units), 4282607 (2 units), 4282612 (2 units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by facsimile on December 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected by apheresis using a machine that failed quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0275-11
CODE
Unit: 020FE02040
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Boise, ID, by telephone or electronic notification on September 5, 2006.
Manufacturer: Lewis and Clark Region-Montana, Great Falls, MT. 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-0276-11
CODE
Unit: 7434755
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile on August 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0308-11;
2) Plasma Frozen. Recall # B-0309-11
CODE
1) and 2) Unit: 21LK14585
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by telephone on March 1, 2006 and by letter dated March 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a dental graft within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0310-11
CODE
Unit: 21LC56566
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by telephone on January 31, 2006 and by letter dated February 2, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a bone graft within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0318-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0319-11;
3) Plasma, Frozen. Recall # B-0320-11;
4) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0321-11
CODE
1) Units: 017GV61498, 017GK50799, 017GK51030, 017GK51547;
2) Units: 017GV61577, 017GW23017, 017FF51091, 017FM36495, 017FM36649, 017FM36994, 017FR63396, 017GF79426, 017GF79514, 017GN63700;
3) Units: 017FF51125, 017FR63396;
4) Unit: 017FF51125
RECALLING FIRM/MANUFACTURER
American National Red Cross (The) - North Central Region, Saint Paul, MN, by telephone on March 13, 2008 and by facsimile on March 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose body temperature was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
MN, WI, IL
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713. ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0040-2011;
2) Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714. ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0041-2011;
3) Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715. ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0042-2011;
4) Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716. ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0043-2011;
5) Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717. ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0044-2011;
6) Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713F (Refurbished). ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0045-2011;
7) Smith & Nephew Aimer Endofemoral 4mm Offset (Purple) Catalog Number: 72201714F (Refurbished). ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0046-2011;
8) Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished). ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0047-2011;
9) Smith & Nephew Aimer Endofemoral 4mm offset (Green) Catalog Number: 72201716F (Refurbished). ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. Recall # Z-0048-2011
CODE
1) Lot Numbers: 50263066, 50270507, 502705071, 50275309, 50278011, 50291507, 50294877;
2) Lot Numbers: 50257057, 50270508, 50275310, 50278012, 50291506, 50294878, 50305399, 502753101, 501753101;
3) Lot Numbers: 50257058, 50270509, 50275311, 50278013, 50291509, 50294879, 50302647, 50304212, 502780131;
4) Lot Numbers: 50263067, 50266541, 50275313, 50294880, 50302648, 50305400, 502780141, 50278014, 50291510;
5) Lot Numbers: 50257076, 50270510, 50275315, 50291511, 50303479, 50278015, 502780151, 50294881;
6) Lot Numbers: 50289236, 50296905;
7) Lot Numbers: 50289069, 50296906;
8) Lot numbers: 50283054, 50296494, 50297288;
9) Lot Numbers: 50283055, 50296495
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover, MA, by letter dated April 29, 2010 and by e-mail.
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
REASON
Endofemoral Aimer tip may separate due to failure of the soldered joint.
VOLUME OF PRODUCT IN COMMERCE
3,108 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela
___________________________________
PRODUCT
1) Scorpio/ NRG 4 in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0049-2011;
2) Scorpio/ NRG 4 in 1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0050-2011;
3) Scorpio/ NRG 4 in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0051-2011;
4) Scorpio/ NRG 4 in 1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0052-2011;
5) Scorpio/ NRG 4 in 1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0053-2011;
6) Scorpio/ NRG 4 in 1 Cutting Block. The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0054-2011;
7) Scorpio/ NRG 4 in 1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0055-2011;
8) Scorpio/ NRG 4 in 1 Cutting Block the Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0056-2011;
9) Scorpio/ NRG 4 in 1 Cutting Block. The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts. Recall # Z-0057-2011
CODE
1) Lot number: 8010-0003;
2) Lot number: 8010-0004;
3) Lot number: 8010-0005;
4) Lot number: 8010-0006;
5) Lot number: 8010-0007;
6) Lot number: 8010-0008;
7) Lot number: 8010-0009;
8) Lot number: 8010-0011;
9) Lot number: 8010-0013
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated August 30, 2010. Firm initiated recall is ongoing.
REASON
Stryker has received reports in which the Cutting Blocks have fractured on impaction during surgery.
VOLUME OF PRODUCT IN COMMERCE
839 units
DISTRIBUTION
Nationwide, Asia, Canada, Europe, Middle East and Africa
___________________________________
PRODUCT
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered by either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular. Recall # Z-0058-2011
CODE
All serial numbers starting with EPC prefix.
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, letter dated August 30, 2010. Firm initiated recall is ongoing.
REASON
Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection.
VOLUME OF PRODUCT IN COMMERCE
8,094 units
DISTRIBUTION
Nationwide, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Netherlands, Singapore, Slovenia, Sweden, Switzerland, and the UK.
___________________________________
PRODUCT
Closed knot pusher REF 902813. The device is intended to push knots down a limb of suture. Recall # Z-0059-2011
CODE
Units: 098750, 278290, 538080, 666270, 864100 and 948870
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated August 2, 2010. Firm initiated recall ongoing.
REASON
The firm has received four complaints that the closed knot pusher is missing a radius which contributes to sutures being cut during surgery.
VOLUME OF PRODUCT IN COMMERCE
101 units
DISTRIBUTION
Nationwide and Belgium, Italy, Argentina, Poland, Netherlands, Turkey, Portugal
___________________________________
PRODUCT
Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22. This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of non-inflammatory degenerative joint disease, including osteoarthritis, fused hip, a vascular necrosis, traumatic arthritis and fracture of the pelvis. Recall # Z-0060-2011
CODE
Unit: 61091653
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by telephone beginning on August 18, 2010. Firm initiated recall is ongoing.
REASON
The threads on the device were not completely machined and therefore would not mate with the corresponding cup positioner/shell inserter.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Control Syringe, 12ml, CAT No: CCS600 Version B, Sterile R, Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0061-2011;
2) Control Syringe, 12ml, CAT No: CCS100 Version B, Sterile R. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0062-2011;
3) Control Syringe, 10ml, CAT No: CCX010 Version B, Sterile R. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0063-2011;
4) Control Syringe, 10ml, CAT No: CCX010E Version B, Sterile R. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0064-2011;
5) Control Syringe, 10ml, CAT No: CCX011 Version A, Sterile R. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0065-2011;
6) Control Syringe, 12ml, CAT No: CCS201E Version B, Sterile R. Used for hand injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty. They are intended to be used as sterile, disposable, single use syringes. Recall # Z-0066-2011
CODE
1) Lot Number: H135352;
2) Lot Number: H137479;
3) Lot Number: H137546;
4) Lot Number: H137552;
5) Lot Number: H137555;
6) Lot Number: H140114
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter dated September 9, 2010. Firm initiated recall is ongoing.
REASON
Small holes in the packaging may render the product non-sterile.
VOLUME OF PRODUCT IN COMMERCE
16,623 units
DISTRIBUTION
IL, PA, WI and WV and China, Greece, Hong Kong, Japan, New Zealand and Spain
___________________________________
PRODUCT
Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; list 1L77-25 The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. Recall # Z-0068-2011
CODE
Lot number: 86599M500, expiration date September 01, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated September 7, 2010.
Manufacturer: Fujirebio Diagnostics, Inc., Malvern, PA. Firm initiated recall is ongoing.
REASON
There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.
VOLUME OF PRODUCT IN COMMERCE
1,995 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxter Interlink System Buretrol Solution Set, 83" (2.1 m), 150 mL Burette Drip Chamber Filter Valve, 2 Injection Sites, Male Luer Lock Adapter, Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set, 38" (97 cm), Vol. 5.8 mL, Injection Site, Male Luer Lock Adapter, 60 DPM; a sterile Rx IV fluid pathway device; product code 3C0166 The administration of fluids from a container into the patient's vascular system through a vascular access device. Recall # Z-0070-2011
CODE
Lot number: GR288365
RECALLING FIRM/MANUFACTURER
Recall Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated September 2, 2010.
Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
There are leaks in the Drip Chamber check Value Subassembly of the Solution Set. A leak in a sterile pathway could allow microbial entry, which could lead to a blood stream infection.
VOLUME OF PRODUCT IN COMMERCE
948 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00. Used to mate the inserter with the shell implant. Recall # Z-0071-2011;
2) Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10. Used to mate the inserter with the shell implant. Recall # Z-0072-2011
CODE
1) Units: 61301130, 61309997, 61326687, 61330544, 61389660, 61407677 and 61426853;
2) Units: 61255960, 61286739, 61293344, 61297228, 61301146, 61303916, 61321619, 61341496, 61341497, 61351886, 61361912, 61361919, 61369266, 61371666, 61371667, 61387139, 61396637 and 61413131
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letters dated March 15, 2010. Firm initiated recall is ongoing.
REASON
The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.
VOLUME OF PRODUCT IN COMMERCE
1,125 units
DISTRIBUTION
Nationwide, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden
___________________________________
PRODUCT
Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, (prior to 2008) and Zimmer Spine (7/2009 to present). Recall # Z-0075-2011
CODE
Units: 20XH, 21SM, 25WG, 29CS, 29YL, 31TL, 32SQ, 33ZK, 34LG, 34XW, 35JW, 36WE, 39BH, 43MP, 44WR, 47EX, 48GF, 48LM, 48MB, 50GD and 50GE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter in February 2010.
Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.
VOLUME OF PRODUCT IN COMMERCE
1,471 units
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland
___________________________________
PRODUCT
Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class 11b. Recall # Z- 0076-2011
CODE
All sequencers for all M/A and MOSAIQ builds.
RECALLING FIRM/MANUFACTURER
Impac Medical Systems, Inc., Sunnyvale, CA, by letter dated September 2010. Firm initiated recall is complete.
REASON
Software issue; matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
VOLUME OF PRODUCT IN COMMERCE
797 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use. Data Cards are not serialized. Recall # Z-0077-2011
CODE
Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010
RECALLING FIRM/MANUFACTURER
Defibtech, LLC, Guilford, CT, by telephone on August 27, 2010. Firm initiated recall is ongoing.
REASON
Data cards may include an incorrect format which may cause the AED to not function correctly.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
EasyRA Cuvette Segment 1, P/N 007000-001 (In Vitro Diagnostic ) EasyRA Cuvette Segments included in the following Kits: EasyRA Cuvettes, REF 10700-4 Startup Kit - Chemistry, REF 10990 Startup Kit - Chemistry & ISE, REF 10991. Recall # Z-0078-2011
CODE
Lot Numbers: 2009/A2810, 2009/A2910, 2009/A3010, 2010/A2001, 2010/A21 01, 2010/A1901, 2009/A0211, 2009/A0311
RECALLING FIRM/MANUFACTURER
Medica Corp., Bedford, MA, by letter dated March 29, 2010. Firm initiated recall is ongoing.
REASON
Chemistry analyzers may report Calcium results below the sample's actual concentration. Reported results may be ten to fifteen percent lower than expected sample results. The defect is a shortened path length at specific cuvette positions of those segments manufactured using molding cavity 1. The shortened path length was determined by measuring the cuvette dimensions with a Co-ordinate Measuring Machine (CMM) and comparing results to the cuvette dimension specification of 6 mm. The firm claims that segments manufactured using molding cavity 2 are not affected. The defect was first discovered after the firm received one customer complaint on February 2010 that reported negative bias of 10-15% in calcium every 20-30 patient samples. Internal testing completed by the firm using EasyQC quality control material resulted in low calcium recovery when using defective cuvette segments.
VOLUME OF PRODUCT IN COMMERCE
14,925 units
DISTRIBUTION
Nationwide, Bulgaria, Canada, India, Mexico, Panama, Philippines, Russia, Turkey, New Zealand, South Africa, United Arab Emirates, and Venezuela
___________________________________
PRODUCT
1) R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0079-2011;
2) R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0080-2011;
3) R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0081-2011;
4) R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0082-2011;
5) R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0083-2011;
6) R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0084-2011;
7) R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0085-2011;
8) R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339166, STERILE EO, QTY 1, Hip prosthesis acetabular component. Acetabular Liner. Recall # Z-0086-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, via e-mail and letter dated August 13, 2010. Firm initiated recall is ongoing.
REASON
The firm received reports of a femoral head popping out of the liner intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
716 units
DISTRIBUTION
Nationwide, Australia and Portugal
___________________________________
PRODUCT
Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion. A total of 136 Catalog Numbers of the suspect device were affected by the firm's corrective action. They are as follows: 22-10-0118 22-10-0366 22-12-4016 22-17-4515 22-20-0351 22-21-4017 22-10-0120 22-10-0369 22-12-4018 22-17-4517 22-20-0354 22-21-4018 22-10-0122 22-10-0372 22-13-4513 22-18-4513 22-20-0357 22-22-4511 22-10-0124 22-10-0375 22-13-4515 22-18-4515 22-20-0360 22-22-4513 22-10-0126 22-10-0468 22-13-4517 22-18-4517 22-20-0363 22-22-4515 22-10-0128 22-10-0472 22-14-4513 22-20-0118 22-20-0366 22-22-4517 22-10-0130 22-10-0476 22-14-4515 22-20-0120 22-20-0369 22-22-4519 22-10-0132 22-10-0480 22-14-4517 22-20-0122 22-20-0372 22-23-4010 22-10-0134 22-10-0484 22-15-4010 22-20-0124 22-20-0375 22-23-4011 22-10-0231 22-10-0488 22-15-4012 22-20-0126 22-20-0468 22-23-4012 22-10-0234 22-10-0492 22-15-4013 22-20-0128 22-20-0472 22-23-4013 22-10-0237 22-11-4010 22-15-4014 22-20-0130 22-20-0476 22-23-4014 22-10-0240 22-11-4012 22-15-4015 22-20-0132 22-20-0480 22-23-4015 22-10-0243 22-11-4013 22-15-4016 22-20-0134 22-20-0484 22-23-4016 22-10-0246 22-11-4014 22-15-4018 22-20-0231 22-20-0488 22-23-4017 22-10-0249 22-11-4015 22-16-4010 22-20-0234 22-20-0492 22-23-4018 22-10-0252 22-11-4016 22-16-4012 22-20-0237 22-21-4010 22-24-4511 22-10-0348 22-11-4018 22-16-4013 22-20-0240 22-21-4011 22-24-4513 22-10-0351 22-12-4010 22-16-4014 22-20-0243 22-21-4012 22-24-4515 22-10-0354 22-12-4012 22-16-4015 22-20-0246 22-21-4013 22-24-4517 22-10-0357 22-12-4013 22-16-4016 22-20-0249 22-21-4014 22-24-4519 22-10-0360 22-12-4014 22-16-4018 22-20-0252 22-21-4015 22-10-0363 22-12-4015 22-17-4513 22-20-0348 22-21-4016. Recall # Z-0087-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Theken Spine LLC, Akron, OH, by letter dated July 29, 2010. Firm initiated recall is ongoing.
REASON
The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures.
VOLUME OF PRODUCT IN COMMERCE
1,081 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. Recall # Z-0088-2011
CODE
Versions 4.0.4.7, 4.5.1.3
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letters on July 19, 2010. Firm initiated recall is ongoing.
REASON
Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Ten Shooter Saeed Multi-Band Ligator, Rx Only. This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids. Product Order Number: a) MBL-10, b) MBL-10-F, c) MBL-10-I, d) MBL-10-XS. Recall # Z-0091-2011;
2) Six Shooter Saeed Multi-Band Ligator, Rx Only. This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids. Product Order Number: a) MBL-10, b) MBL-10-F, c) MBL-10-I, d) MBL-10-XS. Recall # Z-0092-2011
CODE
1) and 2) a) Lot No. W2758471, W2758472, W2758474, W2760365, 2760366, 2760380, W2763652, W2764330, W2764331, W2764332, W2772073, W2772074 and W2772075; b) Lot No. W2763624, W2763626, W2763634, W2767450, W2768607, W2768615, W2768616, W2768617, W2770052, W2773557 and W2773558; c) Lot No. W2767442; d) Lot No. W2787044, W2795540 and W2796313
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter dated September 3, 2010, and by email. Firm initiated recall is ongoing.
REASON
A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.
VOLUME OF PRODUCT IN COMMERCE
2,011 units
DISTRIBUTION
Nationwide, and the countries of Algeria, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Mexico, Malaysia, Morocco, Netherlands, New Zealand, Peru, Poland, Portugal, South Africa, Slovakia, Spain, Switzerland, United Arab Emirates, UK and Venezuela
___________________________________
PRODUCT
1) Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396. Recall # Z-0093-2011;
2) Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399. Recall # Z-0094-2011;
3) Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403. Recall # Z-0095-2011
CODE
1) Lot numbers: EB515 GB501 HB489 KB431 KB529 LB412 LB436 LB437 421412 422509 423818 423819 423820;
2) Lot numbers: EB514 FB465 GB498 GB449 HB544 HB545 KB438 KB538 KB436 KB527 LB554 LlB555 AC464 421417 421418 421419 422512 423826 423076 423827 423828 423829 423830 423075 HB499;
3) 09A0061 09B0310 09C0708 09C0709 09E1139 09F1516 09F1517 09G1830 09H2170 09J2622 09H2170 09J2622 09L3080 10B0196 10B0317 10C0442 10B0318 10C0442 Lot numbers: 8L2688
RECALLING FIRM/MANUFACTURER
Recalling Firm: Codman & Shurtleff, Inc., Raynham, MA, by letter dated July 16, 2010
Manufacturer: Carwild Corp., New London, CT. Firm initiated recall is ongoing.
REASON
Surgical Pattie x-ray stripe (radio-opaque marker) may become detached.
VOLUME OF PRODUCT IN COMMERCE
5,309 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only. Recall # Z-0096-2011;
2) Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only. Recall # Z-0097-2011;
3) Stryker PainPump2 blockAid 400 mL Painpump for continuous Nerve Block, REF 575-100, Sterile, Rx only. Recall # Z-0098-2011
CODE
1) Units: '09160012, '09163012, '09176012, '09197012, '09198012, '09203012, '09211012, '09213022, '09217012, '09222012, '09230012, '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, and '10039022;
2) Units: '09162012, '09163012, '09208012, '09215012, '09223012, '09232012, '09238012, '09246012, '09259012, '09266012, '09280012, '09287012, '09300012, '09303012, '09351012, '09352012, '09353012, '09355022, '09356012, '09362022, '10005012, '10007012, '10008012, '10011012, '10047012, '10048012, '10049012, '10050012, '10074022, '10076012, '10077012, '10078012, '10081022, '10102022, '10103012, '10104012, '10105012, '10106012, '10109022, '10110012, '10111022, '10112032, '10113012, '10116022, '10117012, '10118012, '10119012, '10120012, '10123022, '10124012, '10153012, '10154012 and '10155012;
3) Units: '09049012, '09152022, '09168012, '09169012, '09170012, '09171012, '09173032, '09174012, '09175012, '09177012, '09178012, '09180022, '09201022, '09202012, '09204012, '09205012, '09209012, '09210012, '09212012, '09215012, '09216012, '09218012, '09219012, '09220012, '09222022, '09224012, '09225012, '09226012, '09229022, '09231012, '09233012, '09236022, '09237012, '09239022, '09243022, '09244012, '09245012, '09247012, '09252022, '09253012, '09254012, '09257022, '09260012, '09261012, '09264022, '09265012, '09268012, '09268022, '09271022, '09274012, '09275012, '09278022, '09279012, '09281012, '09282012, '09285022, '09286012, '09287012, '09288012, '09294012, '09295012, '09296012, '09299022, '09300012, '09302012, '09303012, '09306022, '09307012, '09343022, '09344012, '09345012, '09346012, '09348022, '09349012, '09350012, '09351012, '09352012, '09355012, '09356012, '09357012, '09362012, '09363012, '09364012, '10004022, '10005012, '10008012, '10011022, '10012012, '10013012, '10015012, '10019012, '10020012, '10021012, '10022012, '10025012, '10026012, '10027012, '10028012, '10041022, '10042012, '10043022, '10048012, '10049012, '10053022 and '10054022
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments, Division of Stryker Corp., Kalamazoo, MI, by letters dated August 16, 2010.
Manufacturer: Stryker Puerto Rico, Ltd, Arroyo, PR. Firm initiated recall is ongoing.
REASON
The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential risks when using anticoagulants in epidural applications.
VOLUME OF PRODUCT IN COMMERCE
11,976 units
DISTRIBUTION
Nationwide, Canada, Australia
___________________________________
PRODUCT
1) Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: "Philips...Mobile C-Arm systems BV Pulsera". Recall # Z-0140-2011;
2) Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura". Recall # Z-0141-2011
CODE
1) Site numbers: 547349, 547350, 547351, 547352, 549207, 549235, 549260, 549262, 549390, 549822, 551605, 552327, 553176, 553177, 553178, 553206, 553274, 553296, 553650, 553694, 553855, 555645, 556518, 556920, 557506, 557564, 558453, 558455, 558862, 559963, 41443746, 41446009, 41446185, 41446396, 41701188, 41711608, 41750289, 41750637, 41765919, 41767945, 41783430, 41783704, 41794417, 41832433, 41986793, 41997886, 43207053, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543460, 543461, 543462, 543463, 543464, 543465, 543561, 543562, 543616, 543828, 543862, 544191, 544301, 544367, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544603, 544622, 544905, 544925, 544926, 544972, 544984, 545032, 545039, 545085, 545102, 545103, 545136, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546026, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546580, 546680, 546687, 546788, 546790, 546791, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547199, 547221, 547284, 547288, 547298, 547299, 547375, 547602, 547603, 547604, 547605, 547606, 547643, 547656, 547684, 547710, 547712, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548309, 548354, 548358, 548385, 548397, 548398, 548399, 548569, 548602, 548614, 548653, 548700, 548702, 548731, 548733, 548743, 548781, 548782, 548790, 548853, 548929, 548972, 548975, 548984, 548992, 548996, 549005, 549006, 549021, 549025, 549027, 549049, 549059, 549060, 549061, 549063, 549064, 549065, 549070, 549071, 549072, 549081, 549112, 549113, 549114, 549115, 549116, 549117, 549118, 549119, 549120, 549121, 549122, 549125, 549126, 549127, 549128, 549129, 549130, 549132, 549133, 549136, 549137, 549139, 549140, 549142, 549143, 549144, 549171, 549218, 549221, 549231, 549241, 549272, 549273, 549274, 549275, 549287, 549301, 549397, 549403, 549404, 549405, 549406, 549407, 549519, 549520, 549528, 549540, 549563, 549583, 549596, 549618, 549632, 549674, 549694, 549706, 549708, 549727, 549728, 549732, 549733, 549749, 549752, 549758, 549773, 549855, 549878, 549964, 549968, 549993, 550022, 550023, 550056, 550066, 550113, 550121, 550123, 550125, 550128, 550131, 550136, 550183, 550184, 550186, 550189, 550190, 550200, 550252, 550264, 550298, 550372, 550379, 550416, 550426, 550427, 550428, 550450, 550523, 550524, 550541, 550551, 550562, 550603, 550649, 550651, 550653, 550728, 550762, 550805, 550808, 550809, 550819, 550820, 550822, 550840, 550844, 550847, 550856, 550865, 550875, 550879, 550923, 550925, 550971, 550982, 551013, 551020, 551023, 551024, 551033, 551034, 551039, 551128, 551132, 551133, 551134, 551135, 551136, 551137, 551139, 551142, 551190, 551191, 551212, 551262, 551264, 551277, 551292, 551293, 551300, 551329, 551331, 551332, 551333, 551366, 551367, 551368, 551369, 551373, 551381, 551384, 551388, 551400, 551422, 551425, 551427, 551428, 551444, 551445, 551473, 551475, 551476, 551478, 551487, 551506, 551507, 551513, 551518, 551524, 551528, 551529, 551530, 551531, 551532, 551533, 551534, 551536, 551537, 551538, 551539, 551546, 551547, 551548, 551549, 551580, 551591, 551592, 551594, 551621, 551624, 551646, 551685, 551686, 551687, 551688, 551712, 551713, 551723, 551729, 551764, 551797, 551813, 551820, 551822, 551840, 551854, 551882, 551885, 551952, 551967, 551992, 552014, 552015, 552016, 552017, 552018, 552034, 552070, 552075, 552103, 552113, 552121, 552122, 552157, 552161, 552182, 552225, 552226, 552228, 552229, 552230, 552231, 552232, 552233, 552234, 552235, 552236, 552237, 552239, 552240, 552241, 552242, 552243, 552244, 552245, 552246, 552247, 552248, 552249, 552250, 552251, 552262, 552265, 552291, 552292, 552297, 552298, 552299, 552308, 552310, 552312, 552334, 552335, 552336, 552365, 552386, 552387, 552401, 552402, 552403, 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2) Site Numbers: 41955473, 544982, 546114, 546792, 546793, 547164, 548598, 548686, 548983, 549986, 549987, 550126, 550127, 550281, 550409, 550838, 550959, 551127, 551274, 551492, 551525, 551589, 551695, 551730, 552376, 552393, 552394, 552398, 552444, 552467, 552468, 552669, 552990, 553098, 553171, 553271, 553860, 553917, 553976, 553989, 554350, 554363, 554497, 554507, 554658, 554779, 555001, 555021, 555243, 555395, 555463, 555517, 555821, 556135, 556171, 556192, 556202, 556215, 556531, 556587, 556608, 556612, 556678, 556862, 556947, 556977, 556979, 557037, 557063, 557147, 557510, 557520, 557590, 558233, 558237, 558613, 558868, 558975, 559070, 559663, 559665, 41416327, 41443832, 41443860, 41445126, 41445430, 41445445, 41445552, 41445931, 41446303, 41566246, 41585083, 41630870, 41658558, 41661638, 41765654, 41796621, 41905206, 41938039, 41957114, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42551956, 42608281, 42639034, 42824768, 42869100, and 42880805
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA,
by letter October 4, 2008.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor.
VOLUME OF PRODUCT IN COMMERCE
1409 units total (113 BV Endura and 1296 BV Pulsera)
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR NOVEMBER 24, 2010
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