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U.S. Department of Health and Human Services

Safety

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Enforcement Report for July 6, 2011

 

July 6, 2011                                                                                        11-27
 
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Earth Fare Natural, Spicy Bean Burger, 4-2.5 oz (71 g) Patties, Net Weight: 10 oz. Recall # F-1503-2011
CODE
Lot numbers: 05311 and 06711 (printed on master carton)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Earthfare, Fletcher, NC, by email on May 27, 2011 and by press release on June 17, 2011.
Manufacturer: Sol Cuisine Inc., Mississauga, Canada. FDA initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
154 x 10 oz units
DISTRIBUTION
OH
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Old Hickory Brand Banana Extract sold in 2 oz bottles. Recall # F-1495-2011;
2) Old Hickory Brand Peach Extract sold in 2 oz bottles. Recall # F-1496-2011;
3) Old Hickory Brand Sassafras Extract sold in 2 oz bottles. Recall # F-1498-2011;
4) Old Hickory Brand Banana Flavor sold in 2 oz bottles. Recall # F-1499-2011
CODE
All product sold up to and including 4/21/11
RECALLING FIRM/MANUFACTURER
Old Hickory, Co., Punxsutawney, PA, by telephone beginning April 25, 2011. New York initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
5 cases of each flavor (20 cases)
DISTRIBUTION
PA
___________________________________
PRODUCT
Tropical Nuts. Recall # F-1500-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Tropical Nuts, Mayaguez, PR, by visit beginning February 25, 2011. FDA initiated recall is on going.
REASON
Product contains undeclared almonds, but they are visible to consumers.
VOLUME OF PRODUCT IN COMMERCE
About 2,000 units/month
DISTRIBUTION
PR
___________________________________
PRODUCT
1) WD Prestige French Vanilla Ice Cream 1.75 quart. UPC 21140 26985 Plant Code 18-1681. Recall # F-1501-2011;
 
2) WD Prestige Homestyle Vanilla Ice Cream1.75 quart. UPC 21140 26900, Plant Code 18-1681. Recall # F-1502-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Land-o-sun Dairies, LLC, Decatur, IN, by letter on June 14, 2011. Firm initiated recall is ongoing.
REASON
Product contains undeclared color - FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
64,056 cartons
DISTRIBUTION
FL, AL, LA, GA, MS
___________________________________
PRODUCT
Frozen, Battered, Wedge French Fried Potatoes in unlabeled 5 lb brown Kraft bags which are packaged 6 bags to a case. The product was mistakenly placed in the wrong cartons which are labeled in part: "***Ingredients: Potatoes, Partially Hydrogenated Vegetable Oil*** Skincredibles 8 Cut Wedge Frozen Potatoes***005 APR 19 10 02***". The correct cases for the product are labeled in part: "***Battered Wedge Frozen French Fried Potatoes 6 X 5 lb Bags***Ingredients: Potatoes**Enriched Bleached Wheat Flour***Spices***Contains: Wheat***" Recall # F-1504-2011
CODE
Affected Codes: "006MAR311001" "006APR191001" "006APR201001" AND "006JUL181001". CODE BREAKDOWN: 006=Nampa, ID Factory, MAR=March, 31=day of month, 10=year, 01=the manufacturing line.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Simplot Food Group, Boise, ID, by telephone and e-mail on June 23, 2011.
Manufacturer: JR Simplot Co., Nampa, ID. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat. The product was inadvertently put in the wrong cases which did not list wheat as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
235 cases
DISTRIBUTION
CA, AL, SC, FL, MI, PA, TX
___________________________________
PRODUCT
Brady's Home Made Waffle Cones are packaged 11 cones to one plastic sleeve with a twist tie, 19 sleeves are placed in a plastic case for a total of 209 cones per case. The plastic cases have a removable label attached to the top of the case which is reads in part: "USE BY" Dec 2011 or "USE BY October 2011. The product is labeled in parts: "***Brady's HOMEMADE WAFFLE CONES***INGREDIENTS: Enriched Wheat Flour (Bleached Malt Barley Flour, Enriched with (Niacin, Iron (Ferrous Sulfate), Thiamine Mononitrate, Riboflavin, Folic Acid), Sugar, Vegetable Oil (Soybean and/or Canola Oil), Egg Product (Wheat Flour, Soybean Oil, Cellulose Gum, Whole Egg Solids, Lecithin, Salt Sodium Bicarbonate, Annatto and Turmeric), Corn Sugar, Natural & Artificial Flavor, Sweet Whey, Non-Fat Milk, Lecithin, Water***". Recall # F-1505-2011
CODE
USE BY October 2011 or USE BY December 2011
RECALLING FIRM/MANUFACTURER
Brady's Waffle Cone Products, Sedro Woolley, WA, by telephone, visit and letter on June 7, 2011. Firm initiated recall is ongoing.
REASON
Product lists lecithin as an ingredient but does not list soy as the source of the ingredient as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
36 Tubs (209 cones per Tub)
DISTRIBUTION
WA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Old Hickory Brand Raspberry Extract sold in 2 oz bottles. Recall # F-1497-2011
CODE
All product sold up to and including 4/21/11
RECALLING FIRM/MANUFACTURER
Old Hickory, Co., Punxsutawney, PA, by telephone beginning April 25, 2011. New York initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
5 cases
DISTRIBUTION
PA
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) STUD Capsule For Men***1 CAPSULE INSIDE*** Herbal Supplement. Made In The USA***UPC 7 83259 00051 8. Recall # D-594-2011;
 
2) Nite Rider Maximum Sexual Enhancer For Men***Contains Lactose (Milk) Products***1 CAPSULE INSIDE*** Made In The USA***UPC 8 32590 06399 4. Recall # D-595-2011
CODE
All lots distributed from June 1, 2008 to January 7, 2011
RECALLING FIRM/MANUFACTURER
Kanec USA, Inc., Davie, FL, by telephone on January 7, 2011, by press release on January 22, 2011 and by letter between January 19, 2011 and January 24, 2011. Firm initiated recall is ongoing.
REASON
Marketed Without an NDA/ANDA: FDA Laboratory analysis identified Sildenafil, an ingredient in a FDA approved drug to treat Erectile Dysfunction in both products.
VOLUME OF PRODUCT IN COMMERCE
1) Unknown; 2) 9,600 capsules
DISTRIBUTION
FL, NY
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Highly Concentrated (400 mEq/L) Potassium Chloride Injection, 20 mEq, 50 mL, Ready to Use, Viaflex Plus Container, Rx Only, NDC 0338-0703-41. Recall # D-589-2011;
 
2) Highly Concentrated (200 mEq/L) Potassium Chloride Injection, 20 mEq, 100 mL, Ready to Use, Viaflex Plus Container, Rx Only, NDC 0338-0705-48. Recall # D-590-2011
CODE
1) Lot #: P254136, P254136A, Exp 07/11; P252700, Exp 05/11;
2) Lot #: P262766, Exp 01/12; P263673, Exp 02/12; P259705, P259705A, Exp 11/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated Jun 8, 2011.
Manufacturer: Baxter Healthcare Corp., Jayuya, PR. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; Five lots and 2 sub-lots of Highly Concentrated Potassium Chloride Injection may not meet the bacterial endotoxin specifications due to an error in test interpretation and calculation. A Baxter investigation uncovered an error in the programming of analytical instrumentation and a subsequent misinterpretation of test data that could have resulted in those products not meeting the endotoxin specification. No adverse events have been reported and test results of the reserved batch samples met specifications. As a precautionary measure, Baxter is voluntarily recalling the affected product.
VOLUME OF PRODUCT IN COMMERCE
705,730 Viaflex Plus Containers
DISTRIBUTION
Nationwide, PR, Hong Kong, Singapore, Taiwan and Saudi Arabia
___________________________________
PRODUCT
Ammonium Molybdate Injection, USP, Molybdenum 250 meg/10 mL (25 meg/mL), 10 mL single dose vial, packaged in 25 x 10 mL single dose vials per tray pack, Rx Only; NDC 0517-6610-25, UPC3 05176 61025 2. Recall # D-596-2011
CODE
Lot #: 9409, Exp 06/11
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release and letters dated April 26, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Visual particulate matter was observed in retain and stability samples of Ammonium Molybdate Injection.
VOLUME OF PRODUCT IN COMMERCE
18,350 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Nitrostat (Nitroglycerin) Tablets USP, 0.4mg, 1/150 gr, 4 bottles x 25 sublingual tablets, NDC # 0071-0418-13. Recall # D-597-2011;
 
2) Nitrostat (Nitroglycerin) Tablets USP, 0.6mg 4 bottles X 25 sublingual tablets. Recall # D-598-2011
CODE
1) Lot #: V100670, Exp 09/12;
2) Lot #: V100546, Exp 03/13
RECALLING FIRM/MANUFACTURER
Pfizer Pharmaceuticals LLC, Vega Baja, PR, by telephone on May 18, 2011. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: A bottle of Nitrostat 0.6 mg tablets, Lot # V100546, was discovered in a folding carton of Nitrostat 0.4 mg x 4 bottles/carton, Lot # V100670. Nitrostat 0.6mg Lot V100546 is not intended for sale in US market.
VOLUME OF PRODUCT IN COMMERCE
56,644 cartons
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) HydrALAzine Hydrochloride Tablets, USP, 10 mg, a) 100-count bottle (NDC # 50111-398-01), b) 1000-count bottle (NDC # 50111-398-03), Rx Only. Recall # D-599-2011;
 
2) HydrALAzine Hydrochloride Tablets, USP, 25 mg, a) 100-count bottle (NDC # 50111-327-01), b) 1000-count bottle (NDC # 50111-327-03), Rx Only. Recall # D-600-2011;
 
3) HydrALAzine Hydrochloride Tablets, USP, 50 mg, a) 100-count bottle (NDC # 50111-328-01), b) 1000-count bottle (NDC # 50111-328-03), Rx Only. Recall # D-601-2011;
 
4) HydrALAzine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, NDC 50111-397-01. Recall # D-602-2011
CODE
1) Lot #: a) 317041, Exp 01/12, b) 313344, Exp 08/11; 315613, Exp 12/11; 317042, Exp 01/12;
 
2) Lot #: a) 317596, Exp 05/12; 317967, Exp 06/12; b) 313982, Exp 10/11;
 
3) Lot #: a) 14015710A, Exp 01/13; 317053, Exp 04/13; b) 317057, Exp 03/13; 14174210A, Exp 08/13;
 
4) Lot #: 14115410A, Exp 05/13; 14120210A, Exp 06/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 2, 2011, April 1, 2011 and on April 22, 2011.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Tablet Thickness: Some tablets may not conform to weight requirements/specifications.
VOLUME OF PRODUCT IN COMMERCE
70,432 bottles
DISTRIBUTION
Nationwide, PR
___________________________________
PRODUCT
Heimlich Natural Clear Cream, 30 mL jars, UPC# 7 290012 472589; and 50 mL jars, UPC# 7 290011 285609. Recall # D-612-2011
CODE
Lots B-0343 and B-0011
RECALLING FIRM/MANUFACTURER
Recalling Firm: C&C Natural Solution Corp., Brooklyn, NY, by letters dated May 9, 2011.
Manufacturer: Heimlich Natural Products, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Labeling; Product contains undeclared active ingredient; FDA analysis revealed the presence of up to 0.04% Betamethasone Valerate, a corticosteroid.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Genuine Bayer Aspirin (NSAID) Pain Reliever/Fever Reducer, 325 mg, 500 coated tablets, Bayer Healthcare LLC, UPC # 3-12843-54435-2, NDC 0280-2000-51. Recall # D-592-2011
CODE
Lot # 228301D (only case #: 00244 to 00294 and 00337 to 00364), Exp 03/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ, by letter on May 23, 2011.
Manufacture: Bayer Corp., Myerstown, PA. Firm initiated recall is ongoing.
REASON
Misbranding: Bottles missing label; Some bottles of Genuine Bayer Aspirin 325 mg, 500 tablets, lot # 228301D (only case #: 00244 to 00294 and 00337 to 00364) are missing the bottle label (packaged in bottle only/no outer box).
VOLUME OF PRODUCT IN COMMERCE
46,200 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cortisporin Otic Solution Sterile (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP), 10 mL dropper bottle, Rx only; NDC# 61570-034-10. Recall # D-603-2011
CODE
Lot A52870
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN, by letter on May 26, 2011.
Manufacturer: DSM Pharmaceuticals Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
Subpotency.
VOLUME OF PRODUCT IN COMMERCE
24,031 dropper bottles
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
1) CAREONE NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 41520-344-05; UPC 341520314599. Recall # D-604-2011;
 
2) AMERICAN FARE NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 49738-344-05; UPC 072000144374. Recall # D-605-2011;
 
3) KROGER NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 30142-344-05; UPC 041260332982. Recall # D-606-2011;
 
4) CVS NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 59779-344-05; UPC 050428090640. Recall # D-607-2011;
 
5) MEIJER NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 41250-344-05; UPC 719283518958. Recall # D-608-2011;
 
6) RITE AID NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 11822-0344-1; UPC 011822323918. Recall # D-609-2011;
 
7) EQUALINE NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 41163-344-05; UPC 041163432673.Recall # D-610-2011;
 
8) TOPCARE NICOTINE POLACRILEX LOZENGE (nicotine), 2 mg, 72 lozenges per box (3 Quit Tube containers of 24); NDC# 36800-344-05; UPC 036800118928. Recall # D-611-2011
CODE
1) through 8) Lot Numbers: 9HE2612, 9HE2614 and 9JE1480
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter on June 14, 2011. Firm initiated recall is ongoing.
REASON
Subpotency.
VOLUME OF PRODUCT IN COMMERCE
14,784 boxes (44,352 Quit Tubes)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CARE ONE, Liquid Bandage, First Aid Antiseptic, 0.3 Fl oz (10 mL), OTC. Recall # D-613-2011
CODE
Lot numbers: LB11031 and LB11038
RECALLING FIRM/MANUFACTURER
Premier Brands of America, Inc., Mount Vernon, NY, by e-mail on May 31, 2011 and by letter on June 9, 2011. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-up: The bottle label lists the active ingredient Salicylic acid while the unit carton label lists the active ingredients Benzethonium Chloride 0.2% and Dyclonine HCl 0.75%. The product is Care One Liquid Bandage, a first aid antiseptic, should contain Benzethonium Chloride 0.2% and Dyclonine HCl 0.75%.
VOLUME OF PRODUCT IN COMMERCE
1,728 units
DISTRIBUTION
NY, NJ, CT, RI, MA, NH, PA, DE, MD, VA, WV, D.C.
___________________________________
PRODUCT
Prazosin HCl Capsules USP, 1 mg, 1000 count bottle, Rx only, NDC 0093-4067-10. Recall # D-614-2011
CODE
Lot numbers: 30205824A, 30207187A, 30211081A, 30212094A, 30212095A, 30212350A, 30212351A
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 11, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation products.
VOLUME OF PRODUCT IN COMMERCE
4,487 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Anecream Lidocaine 4% Cream, Topical Anesthetic Cream, (5) Five Gram Tubes + (10) 3M Tegaderm Transparent Dressings, For Institutional Use Only, NDC 24357-701-07. Recall # D-615-2011
CODE
Lot number: JK04
RECALLING FIRM/MANUFACTURER
D.S.C. Laboratories, Muskegon, MI, by telephone on March 11, 2011. Firm initiated recall is ongoing.
REASON
Presence of foreign substance, small rubber particles may be present in the product.
VOLUME OF PRODUCT IN COMMERCE
47,530 units
DISTRIBUTION
TN
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1507-11;
2) Platelets. Recall # B-1508-11
CODE
1) Units: 1651815, 1639648;
2) Unit: 1639648
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter dated August 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1541-11
CODE
Unit: W128708180491
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on November 25, 2008 and by letter dated March 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1542-11;
2) Red Blood Cells. Recall # B-1543-11
CODE
1) and 2) Unit: W128708160754
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on January 8, 2009 and by letter dated March 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1544-11
CODE
Units: 22GW40463 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on February 25, 2011. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as negative for the S red cell antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1547-11
CODE
Unit: W071211013335
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter April 15, 2011. 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
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1549-11
CODE
Unit: W128708067006
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and follow-up letter on March 25, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1550-11
CODE
Units: I75038149; I75035898; I75035525; I75038523; I75033702; I75033337; I75032165; I75031798; I75031108; I75030673; I75029774; I75029442; I75028725; I75028398; I75027716; I75026661; I75034762; I75034375; I75026307; I75025594; I75025269; I75024639; I75024325; I75023728 ; I75023425; I75019943; I75020336
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, N Las Vegas, NV, by telephone on July 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1551-11
CODE
Units: I75038817; I75038274;I75035919; I75034880; I75034033; I75033713;I75031615; I75031260; I75030500
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, N Las Vegas, NV, by telephone on July 8, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1556-11;
2) Platelets. Recall # B-1557-11;
3) Red Blood Cells. Recall # B-1558-11
CODE
1) and 2) Units: W116109004288; W116109000421;
3) Units: W116109004288; W116109000029
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital & University Health Center, Sioux Falls, SD, by letter on May 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of Hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
SD
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1561-11;
2) Red Blood Cells. Recall # B-1562-11
CODE
1) and 2) Unit: W128708121235
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on November 25, 2009 and letter on January 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1565-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1566-11;
3) Recovered Plasma. Recall # B-1567-11
CODE
1) 8525260; 8522853; 8507456;
 
2) Units: 8525260; 8522853; 8517550; 8515271; 8513342; 8509087; 8507456; 8505943;
 
3) Units: 8517550; 8515271; 8513342; 8509087; 8505943
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on October 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
1) Platelets. Recall # B-1637-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1638-11
CODE
1) Unit: W035210156611Y;
2) Units: W035210156611Y; W035209232370I
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter and electronic mail on May 20, 2011. 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
3 units
DISTRIBUTION
TX, Austria
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1640-11;
2) Fresh Frozen Plasma. Recall # B-1641-11;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1642-11
CODE
1) and 2) Unit: W036810211866;
3) Unit: W036810826114
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone and letter on April 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1643-11;
2) Fresh Frozen Plasma. Recall # B-1644-11
CODE
1) and 2) Unit: W036310582372
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on April 7, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1645-11;
2) Cryoprecipitated AHF, Pooled. Recall # B-1646-11
CODE
1) Unit: W038110366385;
2) Unit: W038110988542
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers - Lake Park, Palm Beach Gardens, FL, by telephone and letter on April 22, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1647-11
CODE
Unit: W288411000289
RECALLING FIRM/MANUFACTURER
Lifesource, Rosemont, IL, by telephone on April 16, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1649-11
CODE
Units: W142811083670 (part 1); W142811083670 (part 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-counties Blood Bank, San Luis Obispo, CA, by letter on May 25, 2011.
Manufacturer: Tri-counties Blood Bank Dba Ubs Central Coast, Ventura, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1651-11;
2) Recovered Plasma. Recall # B-1652-11
CODE
1) and 2) Unit: W043210088387
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on May 3, 2011. 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, GA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1653-11;
2) Platelets Pooled. Recall # B-1654-11;
3) Cryoprecipitated AHF. Recall # B-1655-11
CODE
1) and 3) Unit: W036811044088;
2) Unit: W036811801380
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone on May 5, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1656-11;
2) Platelets Leukocytes Reduced. Recall # B-1657-11;
3) Red Blood Cells. Recall # B-1658-11
CODE
1) Units: 2314255; 2377217;
2) Unit: 2907534;
3) Units: 2377217; 2261986; 2314255
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lauderhill, FL, by telephone on April 13, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1659-11
CODE
Unit # W089811002601
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by telephone April 24, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled as irradiated, but had not undergone irradiation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1660-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1661-11
CODE
1) Unit: W036810139757;
2) Unit: W036810813685
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on April 11, 2011 and letter on April 20, 2011. 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
Switzerland, FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1663-11;
2) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1664-11
3) Platelets. Recall # B-1665-11
CODE
1), 2), and 3) Unit; 2462339
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Hialeah, FL, by telephone and letter on April 5, 2011. 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
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-1666-11;
2) Fresh Frozen Plasma. Recall # B-1667-11;
3) Red Blood Cells. Recall # B-1668-11;
4) Cryoprecipitated AHF. Recall # B-1669-11;
5) Platelets. Recall # B-1670-11
CODE
1) Unit: W036810822720;
2) Units: W036810213433; 1526631;
3) Units: 1526631; 1449264;
4) Unit: 1449264;
5) Units: 1526631; 1449264
RECALLING FIRM/MANUFACTURER
Community Blood Centers/South Florida, Inc., Lauderhill, FL, by telephone on April 5, 2011 and letter on April 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
FL
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1493-11
CODE
Unit # 03KF38576
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by electronic mail on April 28, 2011. 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
AL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1516-11
CODE
Units: W088411507422, W088411507380, W088411508682, W088411507418
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by telephone and facsimile on April 26, 2011. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
HI
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1563-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1564-11
CODE
1) and 2) Unit: W128708016651
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter on May 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a human corneal tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1639-11
CODE
Unit: W035209232370I
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter and electronic mail on May 20, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1648-11
CODE
Unit: 3410058136
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Winston Salem, NC, by facsimile on May 24, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1650-11
CODE
Unit: 033FN29401
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by electronic mail on April 11, 2011. 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
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1662-11
CODE
Unit: W036810139757
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on April 11, 2011 and letter on April 20, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland, FL
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2233-2011;
 
2) MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2234-2011;
 
3) MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2235-2011;
 
4) Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in incubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807. Recall # Z-2236-2011
CODE
1) Lot Numbers: M8406P10 M8544B11;
2) Lot Numbers: M8286M10 M8300M10 M8406P10 M8544B11 M8555B11 M8575B11;
3) Lot Numbers: M8286M10 M8300M10 M8544B11;
4) Lot Numbers: M8535B11 M8573B11
RECALLING FIRM/MANUFACTURER
Oridion Medical 1987 Ltd, Jerusalem, Israel, by telephone, email and letter dated March 25, 2011. Firm initiated recall is ongoing.
REASON
Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.
VOLUME OF PRODUCT IN COMMERCE
303, 825 units (31,500 units affected -11,100 USA and 20,400 foreign)
DISTRIBUTION
Nationwide Internationally
___________________________________
PRODUCT
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, glucose monitoring test strips. Recall # Z-2570-2011
CODE
Lot Number 470049, expiration date 12/31/2011.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by press release on May 18, 2011. Firm initiated recall is ongoing.
REASON
Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.
VOLUME OF PRODUCT IN COMMERCE
27,019 units
DISTRIBUTION
France Only
___________________________________
PRODUCT
1) Integra LifeSciences Corporation Disposable, Convenience Kit PICC INSERTION TRAY Reorder Number 3403203 Sterile/EO. Recall # Z-2575-2011;
 
2) Integra LifeSciences Corporation Disposable, Convenience Kit PICC INSERTION TRAY Reorder Number 10-2334, Sterile/EO. Recall # Z-2576-2011
CODE
1) Lot/Serial Number(s): W1009188, W1009261, W1011070, W1101120, W1102014, W1103011;
2) Lot/Serial Number: W1101008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp. Plainsboro, NJ, by letter on May 20, 2011.
Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Kits contain protective wipes that may be contaminated with Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
560 trays
DISTRIBUTION
UT
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion. Recall # Z-1678-2011
CODE
Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter dated February 22, 2011. Firm initiated recall is ongoing.
REASON
Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.
VOLUME OF PRODUCT IN COMMERCE
384,180 units
DISTRIBUTION
Nationwide and France
___________________________________
PRODUCT
Precision 500D X-ray systems with under-table collimator part number 5234960 is designed to perform radiographic and fluoroscopic x-ray examinations. Recall # Z-1971-2011
CODE
None
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on June 10, 2010. Firm initiated recall is ongoing.
REASON
Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outside the permitted field without warning to the user. This issue manifests with symptoms wherein the user cannot fully close down the lateral blades.
VOLUME OF PRODUCT IN COMMERCE
440 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lockheed Martin Aculight Capella-r 1850 Laser. The Capella Laser is intended for use in user-defined scientific applications and non-human-use research on infrared nerve stimulation. Recall # Z-2069-2011
CODE
Serial Number: 007
RECALLING FIRM/MANUFACTURER
Lockheed-Martin Aculight, Bothell, WA, by letter on November 19, 2010. Firm initiated recall is ongoing.
REASON
It has been determined that there are certain software driven operating sequences involving off-on cycling of the key-switch that do not result in a reset of the Stim Enable button, and emissions can resume after a standard 5 second countdown without pressing this button a second time.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V Alloy, REF 141224, Sterile, I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement. Recall # Z-2104-2011;
 
2) Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V Alloy, REF 141232, Sterile, I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement. Recall # Z-2140-2011
CODE
1) Lot Number: J100921070;
2) Lot number: J100927055
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by electronic communication on March 3, 2011. Firm initiated recall is ongoing.
REASON
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide, Japan and the Netherlands
___________________________________
PRODUCT
APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. Recall # Z-2129-2011
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 15, 2011.
Manufacturers: Baxter Healthcare Corp., Singapore, Singapore;
Baxter Healthcare Corp., Mountain Home, AR.
Firm initiated recall is ongoing.
REASON
Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of burns, electrocution, fire, or injury to persons: Close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves." Tubing entanglement around the neck may result in loss of consciousness, anoxic brain injury or death if the patient is in an incapacitated state resulting from a fall, seizure, medication effects, or any underlying condition with cognitive impairment and muscle weakness or inability to speak.
VOLUME OF PRODUCT IN COMMERCE
N/A
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01. The data sheet is labeled in part: "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***Spacelabs Healthcare ***Ultraview SL***The Ultraview SL 2700 and SL2800 bedside modules, use external flat panel displays, and include a DC power supply that provides power for the monitor and up to three Flexoria system interfaces. The monitors include interactive networking, graphic and tabular trends, remote view and alarm watch support. They accommodate two single-high parameter SL3800 central monitor includes interactive networking, graphic and tabular trends, remote view, alarm watch, and central alarm manager. The central monitor accommodates a dual-high recorder module, uses an external flat panel display, and includes a DC power supply. In addition to central monitoring, the SL3800 provides bedside monitoring operation through Biomed-level control***". Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexport interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow net worked based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. Recall # Z-2134-2011
CODE
Serial numbers beginning with 1387-1xxxxx
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, LLC, Issaquah, WA, by letter dated April 1, 2011. Firm initiated recall is ongoing.
REASON
The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.
VOLUME OF PRODUCT IN COMMERCE
4470 units worldwide (1891 units in US and 2579 units Internationally)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures. a) Part: 103532; and b) Part: 103533. Recall # Z-2135-2011
CODE
a) Lot: 427460; b) Lot: 502360       
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated March 23, 2011. Firm initiated recall is ongoing.
REASON
One lot of 30 mm screws was switched with one lot of 25 mm screws.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton. Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit. Recall # Z-2136-2011
CODE
Lot number: 198459, Exp. 02-2012; Lot number: 200026, Exp. 03-2012; Lot number: 203031, Exp. 08-2012; Lot number: 204885, Exp. 12-2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vermed, Inc., Bellows Falls, VT, by letter, telephone and e-mail on February 8, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.
VOLUME OF PRODUCT IN COMMERCE
2,500 kits (containing 65,000 alcohol prep pads)
DISTRIBUTION
OR
___________________________________
PRODUCT
NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines. Recall # Z-2137-2011
CODE
Software Versions: 2.0.8100, 3.0.8100, 2.0.8200, 3.0.8200, 2.0.8300, 3.0.8300, 2.0.8400, 3.0.8400, 2.0.8500, and 3.0.8500
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on March 4, 2011.
Manufacturer: Agfa Gevaert Healthcare Gmbh, Peissenberg, Germany. Firm initiated recall is ongoing.
REASON
When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
VOLUME OF PRODUCT IN COMMERCE
775 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
OSSEOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** REF IOSS413***Rx Only***BIOMET 3i Dental Iberica S.L. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Recall # Z-2139-2011
CODE
Lot number: 2009110838
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens, FL, by letter, e-mail or fax on March 14, 2011. Firm initiated recall is ongoing.
REASON
Biomet 3i is recalling their product Osseotite Certain Implant Device IOSS413. The internal thread was not manufactured correctly.
VOLUME OF PRODUCT IN COMMERCE
217 units
DISTRIBUTION
Nationwide, Canada, Europe, Japan, and South America
___________________________________
PRODUCT
Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes. Catalog number K1270. Recall # Z-2154-2011
CODE
Lot numbers: 09224AA, 09286AA, 09350AC, 10011AF, 10047AA, 10089AC, 10089AD, 10131AC and 10131AD
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated June, 2010. Firm initiated recall is ongoing.
REASON
Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
VOLUME OF PRODUCT IN COMMERCE
1,399 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Brightview XCT, 3/8" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. Model number: 4535-607-49161, catalog number 882482. Recall # Z-2155-2011;
 
2) Brightview XCT, 3/4" Philips Medical Systems Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flaot panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. Model number: 4535-604-62131: catalog number 882350. Recall # Z-2156-2011
CODE
1) Serial numbers: 6000150 6000114 6000106 6000071 6000107 6000139 6000138 6000131 6000130 6000128 6000126 6000125 6000123 6000121 6000163 6000156 6000151 6000147 6000145 6000144 6000141 6000120 6000119 6000118 6000109 6000105 6000104 6000103 6000102 6000099 6000098 6000097 6000096 6000088 6000085 6000080 6000077 6000067 6000066 6000041 6000015 6000012 6000010 6000005 6000084 6000074 6000072 6000070 6000065;
 
2) Serial number: 6340008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, San Jose, CA, by letter in April 2011. 
Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.
REASON
The current Headholder to support Bright View XCT brain imaging allowed for imaging the brain but dosen’t allow for imaging of the associated shoulder/neck area of the body.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide and International
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2157-2011
CODE
All Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc. Brea, CA, by letter on February 11, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The recall was initiated because: The handheld barcode scanner does not read barcode labels using NW 7 symbology. Impact: Specimens with NW7 labels cannot be read by the handheld scanner.
VOLUME OF PRODUCT IN COMMERCE
566 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
1) BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2159-2011;
 
2) BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2160-2011;
 
3) BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2161-2011;
 
4) BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2162-2011;
 
5) S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2163-2011;
 
6) S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place. Recall # Z-2164-2011
CODE
1) Lot #: 0006986, Exp Date: 2015-01; Lot #: 0048865, Exp. Date: 2015-02; Lot #: 0211585, Exp. Date: 2015-08; Lot #: 0244725, Exp. Date 2015-09;
 
2) Lot #: 9317747, Exp. Date: 2014-11; Lot #: 0055504, Exp. Date: 2015-03; Lot #: 0168764, Exp. Date: 2015-06; Lot #: 0211586, Exp. Date: 2015-08;
 
3) Lot #: 9314527, Exp Date: 2014-11; Lot #: 9347069, Exp Date: 2014-12; Lot #: 0019451, Exp Date: 2015-01; Lot #: 0048864, Exp Date: 2015-02; Lot #: 0111511, Exp. Date: 2015-04 Lot #: 0193966, Exp Date: 2015-01; Lot #: 0288626, Exp Date: 2015-01; Lot #: 0305287, Exp. Date: 2015-11;
 
4) Lot #: 9314386, Exp Date:2014-04; Lot #: 0006985, Exp Date: 2015-01; Lot #: 0025246, Exp Date 2015-01; Lot #: 0124528, Exp. Date 2015-05 Lot #: 0288625, Exp. Date 2015-05;
 
5) Lot #: 0106446 Exp Date: 2015-04 Lot #: 0152228, Exp Date: 2015-06;
 
6) Lot #: 0106448 Exp. Date: 2015-04
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Co., Waltham, MA, letter dated December 7, 2010. Firm initiated recall is ongoing.
REASON
Restricted or no fluid flow for Visitec High Viscosity Injector.
VOLUME OF PRODUCT IN COMMERCE
19, 129 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus. Recall # Z-2165-2011
CODE
Serial Numbers range: 06050100 -11024479
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Bedford, MA, by letter dated February 2011. Firm initiated recall is ongoing.
REASON
Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results.
VOLUME OF PRODUCT IN COMMERCE
4,379 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes. Recall # Z-2169-2011
CODE
Serial Numbers: 737M51000100 737M51000101 737M51000102 737M51000103 737M51000104 737M51000105 737M51000106 737M51000107 737M51000108 737M51000109 737M51000111 737M51000112 737M51000113 737M51000114 737M51000115 737M51000116 737M51000117 737M51000118 737M51000119 737M51000120 737M51000121 737M51000122 737M51000123 737M51000124 747M51000125 747M51000127 747M51000128 747M51000129 747M51000130 747M51000131 747M51000132 747M51000133 747M51000134 747M51000135 747M51000136 747M51000137 747M51000138 747M51000139 747M51000140 747M51000141 747M51000142 747M51000143 747M51000144 747M51000145 747M51000146 747M51000147 747M51000148 747M51000149 751M51000150 751M51000151 751M51000152 751M51000153 751M51000154 751M51000155 751M51000156 751M51000157 751M51000158 751M51000159 751M51000160 751M51000161 751M51000162 751M51000163 751M51000164 751M51000165 751M51000166 751M51000167 751M51000168 751M51000169 751M51000170 751M51000171 751M51000172 751M51000174 752M51000175 752M51000176 752M51000177 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1036M51002173 1036M51002174 1036M51002175 1036M51002176 1036M51002177 1036M51002178 1036M51002179 1036M51002180 1036M51002181 1036M51002182 1036M51002183 1036M51002184 1036M51002185 1037M51002186 1037M51002187 1037M51002188 1037M51002189 1037M51002190 1037M51002191 1037M51002192 1037M51002193 1037M51002194 1038M51002198 1038M51002199 1038M51002200 1038M51002201 1038M51002202 1038M51002203 1038M51002204 1038M51002205 1038M51002206 1038M51002207 1038M51002208 1038M51002209 1038M51002210 1038M51002211 1038M51002212 1038M51002213 1038M51002214 1038M51002215 1038M51002216 1038M51002217 1038M51002218 1038M51002219 1040M51002220 1040M51002221 1040M51002222 1040M51002223 1040M51002224 1040M51002225 1040M51002226 1040M51002227 1040M51002228
RECALLING FIRM/MANUFACTURER
StatSpin, Inc., dba Iris Sample Processing, Westwood, MA, by letter in August 2010. Firm initiated recall is ongoing.
REASON
Rotors may fail due to wire spokes breaking.
VOLUME OF PRODUCT IN COMMERCE
1,802 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio, and must not be used individually for diagnostic purposes. Recall # Z-2170-2011
CODE
Lot Numbers: 9390 & 9472
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on March 1, 2011. Manufacturer: Beckman Coulter Biomedical Ltd., Clare, Ireland. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032, elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medical actions include additional testing and administration of oral or increased doses of glucose lowering agents.
VOLUME OF PRODUCT IN COMMERCE
373 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling, drainage and fluid injection. Recall # Z-2171-2011
CODE
Lot number: 170314
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated February 22, 2011.
Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Outer box of Monitoring Kit was mislabeled with the incorrect part number.
VOLUME OF PRODUCT IN COMMERCE
45 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2172-2011
CODE
All Serial Numbers are affected
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 11, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The recall was initiated because: Specimen tubes may fall out of a Type A cassette (PN A53551, kit of 20) when the analyzer inverts the cassette in the mixing station, or when an operator manually inverts a cassette The impact: - Specimen tubes may fall out of cassettes and be misplaced inside the instrument - Specimen tubes may break upon impact, causing possible biohazard exposure - Patients may require a redraw for 'lost' or broken tubes.
VOLUME OF PRODUCT IN COMMERCE
566 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated track that connects to Input/Output, Centrifuge, Serum Level Detection, Decapper, and Output modules. The AutoMate TM 800 model also contains and Aliquot module. Recall # Recall # Z-2212-2011
CODE
Lot number - N/A. P/N - A20745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated May 7, 2009.
Manufacturers: Beckman Coulter Inc., Brea, CA; Ids Co., Ltd., Kumamoto, Japan. Firm initiated recall is ongoing.
REASON
The recall was initiated because Beckman Coulter has confirmed an issue with the AutoMate Sample Processing Systems. If during the recovery from Error 81201001, a stuck sample carrier with a tube is moved backwards to the loading position, sample tube/input tray information will become mismatched for samples being loaded onto the AutoMate.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Software Releases A, B, C, D.0, D.01, E.0, E.01, F.0, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. Recall # Z-2217-2011
CODE
Serial Numbers: US: KVN_2479 KVN_2480 KVN_2481 KVN_2482 KVN_2483 KVN_2484 KVN_2485 KVN_7092 KVN_7093 KVN_7094 KVN_7095 KVN_7096 KVN_7097 KVN_7098 KVN_7099 KVN_7100 KVN_7101 KVN_7102 KVN_7103 KVN_7104 KVN_7105 KVN_8808 KVN_8809 KVN_8810 KVN_8811 KVN_8812 KVN_8813 KVN_10274 KVN_10275 KVN_10276 KVN_10277 KVN_2176 KVN_2177 KVN_0397 KVN_0682 KVN_0683 KVN_0684 KVN_0685 KVN_12595 KVN_12596 KVN_8635 KVN_8636 KVN_8637 KVN_8638 KVN_8639 KVN_8640 KVN_8641 KVN_8642 KVN_8643 KVN_8644 KVN_8645 KVN_8646 KVN_8647 KVN_8648 KVN_8649 KVN_8650 KVN_8651 KVN_8652 KVN_8653 KVN_8654 KVN_2811 KVN_2812 KVN_2813 KVN_2886 KVN_2887 KVN_12804 KVN_12805 KVN_12806 KVN_12807 KVN_3552 KVN_3553 KVN_3554 KVN_3555 KVN_3556 KVN_3557 KVN_3558 KVN_3559 KVN_3560 KVN_3561 KVN_3562 KVN_3563 KVN_6159 KVN_0352 KVN_6258 KVN_6259 KVN_6260 KVN_12546 KVN_12547 KVN_12548 KVN_12549 KVN_4714 KVN_4715 KVN_4716 KVN_4717 KVN_4718 KVN_4719 KVN_4720 KVN_4721 KVN_4722 KVN_4723 KVN_4724 KVN_4725 KVN_4726 KVN_4727 KVN_4728 KVN_4729 KVN_4730 KVN_4731 KVN_4732 KVN_10181 KVN_10182 KVN_10183 KVN_10184 KVN_10185 KVN_10186 KVN_10187 KVN_10188 KVN_10189 KVN_10190 KVN_10191 KVN_10192 KVN_0150 KVN_0151 KVN_4952 KVN_4953 KVN_4954 KVN_4955 KVN_6497 KVN_6498 KVN_6499 KVN_6500 KVN_6501 KVN_14119 KVN_0152 KVN_0153 KVN_0154 KVN_0155 KVN_0156 KVN_0157 KVN_0158 KVN_10816 KVN_10817 KVN_10818 KVN_10819 KVN_10820 KVN_10821 KVN_10822 KVN_10823 KVN_10824 KVN_10825 KVN_10826 KVN_10827 KVN_14495 KVN_14496 KVN_14497 KVN_14498 KVN_14499 KVN_14500 KVN_14501 KVN_14502 KVN_10308 KVN_7625 KVN_7626 KVN_7627 KVN_7628 KVN_11312 KVN_11313 KVN_11314 KVN_0018 KVN_0019 KVN_0020 KVN_1286 KVN_1287 KVN_1288 KVN_1289 KVN_1290 KVN_1291 KVN_1292 KVN_1293 KVN_1294 KVN_2048 KVN_2049 KVN_2050 KVN_9157 KVN_1170 KVN_1171 KVN_1172 KVN_1173 KVN_1174 KVN_1175 KVN_1176 KVN_1177 KVN_1178 KVN_1179 KVN_1180 KVN_1181 KVN_1182 KVN_1183 KVN_1184 KVN_1185 KVN_2735 KVN_2736 KVN_2737 KVN_2738 KVN_2739 KVN_2740 KVN_0291 KVN_5484 KVN_5485 KVN_5486 KVN_5487 KVN_5488 KVN_5489 KVN_5490 KVN_5491 KVN_5492 KVN_5493 KVN_5494 KVN_5495 KVN_5496 KVN_14381 KVN_14382 KVN_14383 KVN_14384 KVN_0935 KVN_0936 KVN_0937 KVN_0938 KVN_0939 KVN_12808 KVN_12809 KVN_12810 KVN_12811 KVN_12812 KVN_12813 KVN_12814 KVN_12815 KVN_12816 KVN_12817 KVN_12818 KVN_12819 KVN_12820 KVN_12821 KVN_12822 KVN_12823 KVN_12824 KVN_12873 KVN_12874 KVN_12875 KVN_12876 KVN_12877 KVN_12878 KVN_12879 KVN_12880 KVN_12881 KVN_12882 KVN_14131 KVN_14132 KVN_14133 KVN_14134 KVN_1033 KVN_1034 KVN_2171 KVN_2172 KVN_2173 KVN_2174 KVN_12473 KVN_12474 KVN_1773 KVN_1774 KVN_1775 KVN_1776 KVN_7870 KVN_9843 KVN_9844 KVN_9845 KVN_9846 KVN_9847 KVN_9848 KVN_9849 KVN_9850 KVN_9851 KVN_9852 KVN_9853 KVN_9854 KVN_9855 KVN_9856 KVN_9857 KVN_9858 KVN_9173 KVN_9174 KVN_9175 KVN_9176 KVN_9177 KVN_9178 KVN_9179 KVN_9180 KVN_9181 KVN_9182 KVN_9183 KVN_9184 KVN_9185 KVN_3599 KVN_12886 KVN_0282 KVN_0283 KVN_4871 KVN_4872 KVN_4873 KVN_4874 KVN_4875 KVN_4876 KVN_4877 KVN_4878 KVN_4879 KVN_4880 KVN_4881 KVN_4882 KVN_4883 KVN_4884 KVN_4885 KVN_4886 KVN_4887 KVN_4888 KVN_4889 KVN_4890 KVN_4891 KVN_4892 KVN_4893 KVN_8143 KVN_8144 KVN_8145 KVN_8146 KVN_2196 KVN_2197 KVN_2198 KVN_2199 KVN_2200 KVN_2201 KVN_2202 KVN_2203 KVN_2204 KVN_2205 KVN_2206 KVN_2207 KVN_2208 KVN_2209 KVN_2210 KVN_2211 KVN_2212 KVN_2213 KVN_2214 KVN_2215 KVN_2216 KVN_2217 KVN_2218 KVN_2249 KVN_2250 KVN_2251 KVN_2252 KVN_2253 KVN_2254 KVN_2255 KVN_2256 KVN_2257 KVN_2258 KVN_4850 KVN_4851 KVN_4852 KVN_4853 KVN_4854 KVN_4855 KVN_4856 KVN_4857 KVN_0742 KVN_0743 KVN_0744 KVN_0745 KVN_0746 KVN_0747 KVN_0748 KVN_0749 KVN_10737 KVN_10738 KVN_10739 KVN_7785 KVN_7786 KVN_7787 KVN_7788 KVN_7789 KVN_7790 KVN_7791 KVN_7792 KVN_7793 KVN_7794 KVN_7795 KVN_7796 KVN_7797 KVN_7798 KVN_7799 KVN_7800 KVN_7801 KVN_7802 KVN_7803 KVN_7804 KVN_7805 KVN_7806 KVN_7807 KVN_7808 KVN_7809 KVN_7810 KVN_7811 KVN_7812 KVN_7813 KVN_7814 KVN_7815 KVN_7816 KVN_2507 KVN_2508 KVN_2509 KVN_2510 KVN_2511 KVN_2512 KVN_2513 KVN_2514 KVN_2515 KVN_2516 KVN_8756 KVN_8757 KVN_8758 KVN_8759 KVN_8760 KVN_8761 KVN_8762 KVN_8763 KVN_8764 KVN_12081 KVN_12082 KVN_12083 KVN_12084 KVN_12085 KVN_12086 KVN_12087 KVN_12088 KVN_12089 KVN_12090 KVN_12091 KVN_12092 KVN_12093 KVN_0762 KVN_0763 KVN_0764 KVN_0765 KVN_10968 KVN_10969 KVN_10970 KVN_10971 KVN_10986 KVN_10987 KVN_10988 KVN_10989 KVN_10994 KVN_10995 KVN_10996 KVN_0224 KVN_0225 KVN_0226 KVN_0227 KVN_0228 KVN_0229 KVN_0230 KVN_0231 KVN_0232 KVN_0233 KVN_0234 KVN_0235 KVN_0236 KVN_0237 KVN_0238 KVN_0239 KVN_0240 KVN_0241 KVN_0242 KVN_0243 KVN_0244 KVN_4197 KVN_4198 KVN_4199 KVN_4200 KVN_4201 KVN_4202 KVN_4203 KVN_4204 KVN_0600 KVN_0601 KVN_9543 KVN_9544 KVN_9545 KVN_9546 KVN_9547 KVN_9548 KVN_9549 KVN_9550 KVN_9551 KVN_0680 KVN_0681 KVN_10166 KVN_10167 KVN_10168 KVN_10169 KVN_10170 KVN_10171 KVN_10172 KVN_10173 KVN_10174 KVN_10175 KVN_10176 KVN_10177 KVN_2590 KVN_11341 KVN_11342 KVN_11343 KVN_11344 KVN_11345 KVN_11346 KVN_11347 KVN_11348 KVN_11349 KVN_11350 KVN_11351 KVN_11352 KVN_11353 KVN_11354 KVN_11355 KVN_11356 KVN_11357 KVN_11358 KVN_11359 KVN_11370 KVN_11371 KVN_11372 KVN_11373 KVN_11374 KVN_11375 KVN_11376 KVN_11377 KVN_11378 KVN_11379 KVN_11380 KVN_14477 KVN_14478 KVN_14479 KVN_14480 KVN_14471 KVN_14472 KVN_14473 KVN_14474 KVN_14475 KVN_9162 KVN_2893 KVN_2894 KVN_2895 KVN_2896 KVN_2897 KVN_2898 KVN_2899 KVN_14656 KVN_14657 KVN_2411 KVN_2412 KVN_2413 KVN_2414 KVN_2415 KVN_2416 KVN_2417 KVN_2418 KVN_2419 KVN_2420 KVN_2421 KVN_2422 KVN_2423 KVN_2424 KVN_11695 KVN_11696 KVN_11697 KVN_11698 KVN_11699 KVN_11700 KVN_11710 KVN_11711 KVN_0393 KVN_0394 KVN_7013 KVN_7014 KVN_7015 KVN_7016 KVN_7017 KVN_4205 KVN_4206 KVN_4207 KVN_4208 KVN_4209 KVN_4210 KVN_4211 KVN_4212 KVN_4402 KVN_4403 KVN_2950 KVN_2951 KVN_4118 KVN_4119 KVN_4120 KVN_4121 KVN_4122 KVN_6776 KVN_4291 KVN_4292 KVN_4311 KVN_4312 KVN_4313 KVN_4314 KVN_4315 KVN_4316 KVN_4317 KVN_4318 KVN_4319 KVN_4320 KVN_4326 KVN_4327 KVN_4328 KVN_14481 KVN_14482 KVN_14483 KVN_7315 KVN_7316 KVN_7317 KVN_7318 KVN_7330 KVN_7331 KVN_7332 KVN_14377 KVN_14378 KVN_14379 KVN_14380 KVN_8753 KVN_8754 KVN_8755 KVN_1040 KVN_1041 KVN_1042 KVN_0999 KVN_1000 KVN_1001 KVN_1002 KVN_1003 KVN_1004 KVN_1005 KVN_1006 KVN_1007 KVN_1008 KVN_13714 KVN_13715 KVN_13716 KVN_13717 KVN_13718 KVN_13719 KVN_13720 KVN_13721 KVN_13722 KVN_13723 KVN_13724 KVN_13725 KVN_0277 KVN_0278 KVN_4646 KVN_4647 KVN_4648 KVN_4649 KVN_4650 KVN_4651 KVN_4652 KVN_4653 KVN_4654 KVN_4655 KVN_4656 KVN_4657 KVN_4658 KVN_4659 KVN_4660 KVN_4661 KVN_4662 KVN_4663 KVN_4664 KVN_4665 KVN_4666 KVN_9726 KVN_9727 KVN_9728 KVN_9729 KVN_9730 KVN_9731 KVN_1426 KVN_1427 KVN_1428 KVN_1429 KVN_14943 KVN_4488 KVN_4489 KVN_4490 KVN_4491 KVN_4492 KVN_4493 KVN_4494 KVN_4495 KVN_4496 KVN_4497 KVN_4498 KVN_4499 KVN_4500 KVN_6478 KVN_6479 KVN_6480 KVN_6481 KVN_1595 KVN_1596 KVN_1597 KVN_1598 KVN_1599 KVN_1600 KVN_1601 KVN_14090 KVN_6425 KVN_6426 KVN_6427 KVN_6428 KVN_6429 KVN_6430 KVN_6431 KVN_6432 KVN_6433 KVN_6434 KVN_6435 KVN_6436 KVN_6437 KVN_6438 KVN_2664 KVN_0690 KVN_10322 KVN_10323 KVN_6795 KVN_6796 KVN_6797 KVN_6798 KVN_6799 KVN_6800 KVN_6801 KVN_6802 KVN_6803 KVN_6804 KVN_6805 KVN_6806 KVN_6807 KVN_6808 KVN_6809 KVN_6810 KVN_6811 KVN_6812 KVN_6813 KVN_6814 KVN_6815 KVN_6816 KVN_6817 KVN_6818 KVN_6819 KVN_6820 KVN_2486 KVN_2487 KVN_11148 KVN_11149 KVN_11150 KVN_11151 KVN_11152 KVN_11153 KVN_11154 KVN_11155 KVN_11156 KVN_11157 KVN_11158 KVN_11159 KVN_11161 KVN_11162 KVN_11163 KVN_11164 KVN_11165 KVN_11166 KVN_11167 KVN_11168 KVN_11169 KVN_11170 KVN_11171 KVN_11172 KVN_11173 KVN_11174 KVN_11175 KVN_11176 KVN_11177 KVN_11178 KVN_11179 KVN_11180 KVN_11181 KVN_11182 KVN_11183 KVN_11184 KVN_11185 KVN_11186 KVN_11187 KVN_11188 KVN_11189 KVN_11199 KVN_11200 KVN_11201 KVN_3157 KVN_5327 KVN_9747 KVN_9748 KVN_9749 KVN_9192 KVN_9193 KVN_9194 KVN_0119 KVN_0120 KVN_4522 KVN_2517 KVN_12115 KVN_12116 KVN_12117 KVN_12118 KVN_12119 KVN_12120 KVN_12121 KVN_12122 KVN_12123 KVN_12124 KVN_12125 KVN_12126 KVN_12127 KVN_12128 KVN_12129 KVN_12130 KVN_12131 KVN_12132 KVN_12500 KVN_12501 KVN_12192 KVN_12193 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KVN_2845 KVN_2846 KVN_2847 KVN_5260 KVN_5261 KVN_5262 KVN_5263 KVN_5264 KVN_5265 KVN_5266 KVN_5267 KVN_5268 KVN_5269 KVN_5270 KVN_0569 KVN_9140 KVN_9141 KVN_9142 KVN_9143 KVN_9144 KVN_9145 KVN_9146 KVN_9147 KVN_9148 KVN_9149 KVN_0793 KVN_0794 KVN_11202 KVN_11203 KVN_11204 KVN_11205 KVN_11206 KVN_11207 KVN_11208 KVN_11209 KVN_11210 KVN_11211 KVN_11212 KVN_11213 KVN_11214 KVN_11215 KVN_11216 KVN_11217 KVN_11218 KVN_11219 KVN_11220 KVN_11221 KVN_11222 KVN_12133 KVN_3325 KVN_3326 KVN_3327 KVN_3328 KVN_3329 KVN_3330 KVN_3331 KVN_3332 KVN_3333 KVN_3334 KVN_3335 KVN_3336 KVN_3337 KVN_3338 KVN_3339 KVN_3340 KVN_3341 KVN_3342 KVN_3343 KVN_3344 KVN_3345 KVN_3346 KVN_3347 KVN_8971 KVN_8972 KVN_8973 KVN_8974 KVN_8975 KVN_8976 KVN_8977 KVN_8978 KVN_8979 KVN_8980 KVN_8981 KVN_6204 KVN_14658 KVN_14659 KVN_2580 KVN_2581 KVN_2582 KVN_2583 KVN_2584 KVN_2585 KVN_2586 KVN_2587 KVN_2588 KVN_2589 KVN_2175 KVN_10677 KVN_10678 KVN_14628 KVN_14629 KVN_14630 KVN_14631 KVN_14632 KVN_14633 KVN_14634 KVN_14635 KVN_14636 KVN_14637 KVN_4219 KVN_4220 KVN_4221 KVN_7232 KVN_7233 KVN_1553 KVN_1554 KVN_1555 KVN_1556 KVN_1557 KVN_1558 KVN_1559 KVN_1560 KVN_1561 KVN_1562 KVN_1563 KVN_1564 KVN_1565 KVN_1566 KVN_1567 KVN_1568 KVN_1569 KVN_1570 KVN_2804 KVN_2805 KVN_4858 KVN_4859 KVN_4860 KVN_4861 KVN_4862 KVN_4863 KVN_4864 KVN_4865 KVN_8192 KVN_8193 KVN_8194 KVN_8195 KVN_8196 KVN_8197 KVN_0374 KVN_0375 KVN_14956 KVN_14957 KVN_6737 KVN_10415 KVN_10416 KVN_14385 KVN_14386 KVN_5557 KVN_4527 KVN_4528 KVN_4529 KVN_4530 KVN_4531 KVN_4532 KVN_4533 KVN_4534 KVN_4535 KVN_4536 KVN_13630 KVN_14038 KVN_14039 KVN_14040 KVN_14041 KVN_14042 KVN_2231 KVN_13470 KVN_13471 KVN_13472 KVN_13473 KVN_13474 KVN_13475 KVN_13476 KVN_13477 KVN_13478 KVN_13479 KVN_13480 KVN_13481 KVN_13482 KVN_13483 KVN_13484 KVN_13485 KVN_13486 KVN_9859 KVN_9860 KVN_6151 KVN_6152 KVN_6153 KVN_6154 KVN_6155 KVN_6279 KVN_9968 KVN_9969 KVN_0038 KVN_0039 KVN_0040 KVN_0041 KVN_0042 KVN_0043 KVN_0044 KVN_0045 KVN_0046 KVN_0047 KVN_0048 KVN_0049 KVN_0050 KVN_0051 KVN_0052 KVN_0053 KVN_0054 KVN_0055 KVN_0056 KVN_0057 KVN_0058 KVN_0059 KVN_0060 KVN_0061 KVN_0062 KVN_0063 KVN_4462 KVN_4463 KVN_4464 KVN_4465 KVN_4466 KVN_4467 KVN_4468 KVN_4469 KVN_4470 KVN_4471 KVN_4472 KVN_4473 KVN_4474 KVN_4475 KVN_4476 KVN_14189 KVN_14190 KVN_13082 KVN_13083 KVN_13084 KVN_13085 KVN_13086 KVN_13087 KVN_13088 KVN_13089 KVN_8275 KVN_8276 KVN_8277 KVN_8278 KVN_8279 KVN_8280 KVN_8281 KVN_8282 KVN_8283 KVN_8284 KVN_8285 KVN_8286 KVN_2115 KVN_6128 KVN_0701 KVN_0702 KVN_10082 KVN_10083 KVN_10084 KVN_10085 KVN_10086 KVN_10087 KVN_10088 KVN_10089 KVN_10090 KVN_10091 KVN_10092 KVN_10093 KVN_10094 KVN_10095 KVN_10096 KVN_10097 KVN_14220 KVN_14221 KVN_14222 KVN_14223 KVN_7735 KVN_7736 KVN_7741 KVN_7742 KVN_7743 KVN_7744 KVN_7765 KVN_7766 KVN_7767 KVN_7768 KVN_7769 KVN_7770 KVN_7771 KVN_1031 KVN_1032 KVN_14357 KVN_14358 KVN_14359 KVN_14111 KVN_14112 KVN_14113 KVN_14114 KVN_14225 KVN_14226 KVN_14227 KVN_14228 Canada KVN_14983 KVN_14970 KVN_14990 KVN_14985 KVN_14995 KVN_14986 KVN_15127 KVN_15002 KVN_14998 KVN_15103 KVN_15104 KVN_15105 KVN_15009 KVN_15012 KVN_15003 KVN_15128 KVN_14977 KVN_14973 KVN_15000 KVN_15106 KVN_15107 KVN_15108 KVN_15109 KVN_15110 KVN_15111 KVN_15112 KVN_15113 KVN_15114 KVN_15004 KVN_14996 KVN_14971 KVN_14969 KVN_15119 KVN_14978 KVN_15122 KVN_15123 KVN_14999 KVN_15006 KVN_14991 KVN_15028 KVN_15137 KVN_15138 KVN_15139 KVN_15140 KVN_15141 KVN_15142 KVN_15143 KVN_15144 KVN_15145 KVN_14980 KVN_15124 KVN_14984 KVN_15125 KVN_15126 KVN_0001 KVN_14988 KVN_15018 KVN_0002 KVN_0003 KVN_0004 KVN_15011 KVN_15132 KVN_2282 KVN_14966 KVN_15115 KVN_15116 KVN_14992 KVN_14993 KVN_14979 KVN_2283 KVN_0005 KVN_0006 KVN_14975 KVN_15120 KVN_15010 KVN_15131 KVN_15001 KVN_15029 KVN_15146 KVN_15147 KVN_15148 KVN_0011 KVN_0012 KVN-0013 KVN_14987 KVN_14997 KVN_15100 KVN_15101 KVN_15102 KVN_15013 KVN_15007 KVN_15129 KVN_15008 KVN_15130 KVN_14989 KVN_15005 KVN_15027 KVN_15030 KVN_15149 KVN_14976 KVN_15121 KVN_15117 KVN_14968 KVN_15118 KVN_14982 KVN_15023 KVN_15024 KVN_0009 KVN_0010 KVN_14994 KVN_14972 KVN_14974 KVN_14981 KVN_0007 KVN_0008
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated April 28, 2011. Firm initiated recall is ongoing.
REASON
PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation.
VOLUME OF PRODUCT IN COMMERCE
15,062 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) AVOXimeter 1000, b) AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use in the cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated. Recall # Z-2218-2011
CODE
a) K922075 AVOX1000, AVOX1000E-110, AVOX1000INT; b) K951485 AVOX4000, AVOX4000D
RECALLING FIRM/MANUFACTURER
International Technidyne Corp. Edison, NJ, by letter dated March 23, 2011. Firm initiated recall is ongoing.
REASON
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide, Taiwan and Thailand
___________________________________
PRODUCT
Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment. Recall # Z-2238-2011
CODE
Serial number 00004; Serial numbers 00001 and 00002
RECALLING FIRM/MANUFACTURER
Maquet Inc., Wayne, NJ, by letter dated April 15, 2011. Firm initiated recall is ongoing.
REASON
Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fiber table tops.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA, MO, VA
___________________________________
PRODUCT
Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric". Recall # Z-2239-2011
CODE
Lot number: HUUF0530
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated April 25, 2011.  
Manufacturer: Bard Shannon LTD, Humacao, PR. Firm initiated recall is ongoing.
REASON
Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6".
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. Recall # Z-2241-2011
CODE
Serial Numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, and N16E100023
RECALLING FIRM/MANUFACTURER
Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China, by letter dated February 9, 2011. Firm Initiated recall is ongoing.
REASON
Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help. Product code 1600-14-50. Recall # Z-2242-2011
CODE
Lot number: 032210
RECALLING FIRM/MANUFACTURER
Salter Laboratories, Division of Regulatory Affairs, Arvin, CA, by letter dated April 19, 2011. Firm initiated recall is ongoing.
REASON
One complaint received of product in box different from what was on label.
VOLUME OF PRODUCT IN COMMERCE
3,500 pieces
DISTRIBUTION
Nationwide and South America
___________________________________
PRODUCT
ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 system; Therapist Express Basic Part number 08515289; syngo RT Therapist Part Number 08162815; and syngo RT Therapist Connect/MOSAIQ OIS Part number 08168754. The ONCOR and PRIMUS may be updated to utilize the RTT v4.x software. Recall # Z-2243-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, letter on March 31, 2011.
Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON
Siemens found a potential safety issue related to patient treatment with table offsets on syngo RT Therapist (RTT) 4.1 and 4.2 which could result in dose being delivered to wrong location.
VOLUME OF PRODUCT IN COMMERCE
164 active devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient suspected of having bacteremial/fungemia. The BacT/ALERT System and culture bottles provide both a microbial detection system and a culture media with suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and other normally sterile body fluid infections. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA bottle. BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacterial and fungi) from blood and other normally sterile body fluids. Catalog number: 259791. Recall # Z-2244-2011
CODE
Lot umber 1027481, Expiry: December 8, 2011
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc., Durham, NC, by Notice dated April 13, 2011. Firm initiated recall is ongoing.
REASON
The charcoal suspension in a portion of the lot does not meet the intended density.
VOLUME OF PRODUCT IN COMMERCE
327,000 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
OSSEOTITE Tapered Certain Implant 4 x 11.5mm, REF INT411***Sterile Using Radiation***Rx Only. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Recall # Z-2245-2011
CODE
Lot number: 963841
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated March 14, 2011. Firm initiated recall is ongoing.
REASON
The product is being recalled because the internal thread was not manufactured correctly.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide, Europe, Japan, Asia, and South America
___________________________________
PRODUCT
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to. Recall # Z-2246-2011
CODE
Units: 35A2Y000, 35AWO000, 5N2N4004, 5NP9X001, 5NSMY000, 5OHXO000, 5QFWU000, E5KN2002, ETQ55000, EU5P6000, EYMFF000, F8AM4771, L18HH000, L2CEW000, L41KH000, L5N26000, L5N4B000, L5N5D000, L5P6O000, L5PD1000, L6S8E000, L8L5U000, L8VHQ000, L9HGC000, LEFG2504, LVTB7007
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letter on April 14, 2011.
Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing.
REASON
Software issue that occurs after dictation of a study.
VOLUME OF PRODUCT IN COMMERCE
95 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2541-2011;
 
2) Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2542-2011;
 
3) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2543-2011;
 
4) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2544-2011;
 
5) Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2545-2011;
 
6) Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2546-2011;
 
7) Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2547-2011;
 
8) Custom biomodular humeral tray 44 mm sterile, REF CP561686. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2548-2011;
 
9) Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2549-2011;
 
10) Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Recall # Z-2550-2011
CODE
1) Units: 6410, M583200, M583210, M907780, M907790 and M907800;
2) Unit: M070320;
 
3) Units: M132050, M153460, M310650, M372360, M372370, M402160, M424790, M451890, M696360, M717580, M717590, M908060 and M926990;
 
4) Units: M016170, M075380, M132040, M153440, M216030, M436800, M482790, M482810, M482820, M482830, M513600, M513610, M513620, M559110, M597720, M620280, M696340, M698060, M717560, M717570, M732600, M788700, M858260, M865130, M906860, M950410, M964940 and M987720;
 
5) Units: M013420, M016140, M016150, M016160, M038910, M041880, M049730, M049740, M052860, M075320, M075330, M075330, M075350, M075360, M075370, M079900, M100140, M118270, M118280, M118390, M153340, M153370, M153380, M153410, M208420, M212200, M212220, M212230, M212240, M215990, M216000, M231070, M256990, M300090, M300100, M300110, M300120, M300140, M300150, M310580, M310590, M310620, M349140, M349150, M351030, M351040, M367300, M367310, M367330, M372310, M372320, M385090, M411980, M415040, M415060, M424640, M424690, M424740, M440500, M492410, M492430, M492450, M556800, M563440, M568870, M569080, M569090, M569100, M569120, M569130, M569140, M569150, M595090, M597740, M613990, M628500, M668560, M668590, M668600, M668610, M668620, M674320, M680740, M680750, M696290, M696300, M697170, M697180, M791260, M791280, M848110, M848290, M848310, M854210, M854240, M854250, M854310, M907820, M907830, M907840, M907850, M907990, M908030, M917830, M934930, M950390, M950400, M963700, M974990, M981260 and M987710;
6) Units: M223830 and M699350;
7) Unit: M950060;
8) Unit: M977790;
 
9) Unit: M617380;
 
10) Units: M068700, M608210, M787230, M810390
RECALLING FIRM/MANUFACTURER
Biomet, Inc. Warsaw, IN, by letter dated April 22, 2011. Firm initiated recall is ongoing.
REASON
The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
VOLUME OF PRODUCT IN COMMERCE
1,575 units
DISTRIBUTION
Nationwide and International
___________________________________
PRODUCT
The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles. Recall # Z-2573-2011
CODE
Serial numbers: 1517-000001, 1517-000002, 1517-000003, 1517-000004, 1517-000005, 1517-000006, 1517-000007, 1517-000008, 1517-000009, 1517-000010, 1517-000011, 1517-000012, 1517-000013, 1517-000014, 1517-000015, 1517-000016, 1517-000017, 1517-000018, 1517-000019, 1517-000020, 1517-000021, 1517-000022, 1517-000023, 1517-000024, 1517-000025, 1517-000026, 1517-000027, 1517-000028, 1517-000029, 1517-000030, 1517-000031, 1517-000032, 1517-000033, 1517-000034, 1517-000035, 1517-000036, 1517-000037, 1517-000038, 1517-000039, 1517-000040, 1517-000041, 1517-000042, 1517-000043, 1517-000044, 1517-000045, 1517-000047, 1517-000049, 1517-000050, 1517-000051, 1517-000052, 1517-000053, 1517-000054, 1517-000055, 1517-000056, 1517-000057, 1517-000058, 1517-000059, 1517-000060, 1517-000061, 1517-000062, 1517-000063, 1517-000064, 1517-000065, 1517-000066, 1517-000067, 1517-000068, 1517-000069, 1517-000070, 1517-000071, 1517-000072, 1517-000073, 1517-000074, 1517-000075, 1517-000076, 1517-000077, 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RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, LLC, Issaquah, WA, by letter dated May 12, 2011. Firm initiated recall is ongoing.
REASON
Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.
VOLUME OF PRODUCT IN COMMERCE
5,883 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
B.Braun Celsa Medical, Celsite Venous Access Ports. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315. Recall # Z-2671-2011
CODE
Lot numbers: J313196U, J312177U, J313197U K021193U, J312178U, J295789U
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter on April 16, 2011.
Manufacturer: B.Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
REASON
The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle is provided dependent on the port size. The clamp of the incorrect needles identifies a maximum pressure of 325 psi; the current winged Surecan needles distributed in the U.S. Celsite package configurations do not identify a maximum pressure. Hazards associated with high pressure injection into these Celsite Access Ports could include: catheter migration and leak/product extravasations.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
NY, ND, OK, PA
___________________________________
PRODUCT
1) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe, Catalog AVHCT. Recall # Z-2678-2011;
 
2) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT. Recall # Z-2679-2011;
 
3) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial and venous blood parameter modules, catalog 500AV. Recall # Z-2680-2011;
 
4) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module, catalog 500A. Recall # Z-2681-2011;
 
5) Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with venous blood parameter module, catalog 500V. Recall # Z-2682-2011;
 
6) Terumo Cardiovascular Systems, CDI 101 Hematocrit/Oxygen saturation monitoring system, catalog 101. Recall # Z-2683-2011;
 
7) Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100. Recall # Z-2684-2011
CODE
1) Lots: 1005-5521;
2) Lots: 1023-5556;
3) Lots: 1193-5340
4) Lots: 1211-5349;
5) Lots: 1564, 1565, and 1566;
6) Lots: 1070-1839;
7) Lots: 100-030 through 100-1687
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated April 21, 2011. Firm initiated recall is ongoing.
REASON
Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K+, Base Excess, Bicarbonate, O2 Saturation, O2 Consumption. Methylene Blue and other vascular dyes could potentially interfere with readings on any CDI system, including the CDI 100 or 101 Hematocrit/Oxygen Saturation Monitor. It is possible that a user would make a decision to administer or withhold treatment during a cardiac surgical procedure based on the readings provided by a CDI system. If the readings were incorrect, then such an action might be incorrect and possibly harmful to a patient. Terumo CVS is updating the Operator's Manuals for all CDI systems with an updated WARNING and CAUTION statement.
VOLUME OF PRODUCT IN COMMERCE
5,582 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Integra NeuroSciences, Combo Kit. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement. Recall # Z-2194-2011
CODE
Lot  number: 171237
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter dated February 22, 2011.
Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, Firm initiated recall is ongoing.
REASON
Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
VOLUME OF PRODUCT IN COMMERCE
7 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB. Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Recall # Z-2551-2011
CODE
Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by telephone and letter dated April 18, 2011.
Manufacturer: Haemanuotec Inc., Quebec, Canada. Firm initiated recall is ongoing.
REASON
Mislabeled: incorrect lot number printed on case labels.
VOLUME OF PRODUCT IN COMMERCE
3,190 cases
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
 
1) Kent SwineMIX PT + LYS/M, Product #2185, packaged in 50-lb. bags. Recall # V-169-2011;
 
2) Kent Super Supplement, Product #2188, packaged in 50-lb. bags. Recall # V-170-2011;
 
3) Kent GL X-Tra Plus, Product #2190, packaged in 50-lb. bags. Recall # V-171-2011;
 
4) Kent Wean-MAX 10-25 D-CTC Medicated, Product #2191, packaged in 50-lb. bags, containing 35 g/ton tiamulin hydrogen fumarate and 600 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl. Recall # V-172-2011;
 
5) Kent Start-Tech 25-40 D-CTC Medicated, Product #2197, containing 35 g/ton tiamulin hydrogen fumarate and 600 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-173-2011;
 
6) Kent Golden K Sow NP, Product #2203, packaged in 50-lb. bags. Recall # V-174-2011;
 
7) Golden K Sow, Product #2206, packaged in 50-lb. bags and in bulk. Recall # V-175-2011;
 
8) Kent Sow Cubes, Product #2228, packaged in 50-lb. bags. Recall # V-176-2011;
 
9) Kent Golden K 137F, Product #2229, packaged in 50-lb. bags and in bulk. Recall # V-177-2011;
 
10) Kent Pig Nugget Mixer, Product #2232, packaged in 50-lb. bags and in bulk. Recall # V-178-2011;
 
11) Kent Pig Nugget Mixer 1000, Product #2234, bulk. Recall # V-179-2011;
 
12) Kent GM Base Supplement, Product #2251, packaged in 50-lb. bags and in bulk. Recall # V-180-2011;
 
13) Kent Gestation 600F, Product #2272, packaged in 50-lb. bags and in bulk. Recall # V-181-2011;
 
14) Kent Gestation 450F, Product #2273, bulk feed. Recall # V-182-2011;
 
15) Kent Gestation 35, Product #2274, packaged in 50-lb. bags. Recall # V-183-2011;
 
16) Kent GL Sow Prime PT, Product #2279, packaged in 50-lb. bags and in bulk. Recall # V-184-2011;
 
17) Kent Ulti-Lact 369, Product #2281, packaged in 50-lb. bags and in bulk. Recall # V-185-2011;
 
18) Kent MaternaLact 367, Product #2282, bulk feed. Recall # V-186-2011;
 
19) Kent Ulti-Lact 369 BMD Medicated, Product #2285, containing 800 g/ton bacitracin methylene disalicylate, packaged in 50-lb. bags and in bulk. Recall # V-187-2011;
 
20) Kent Ulti-Lact 369 NT2560 Medicated, Product #2286, containing 1,280 g/ton oxytetracycline and 1,280 g/ton neomycin sulfate, packaged in 50-lb. bags and in bulk.
Recall # V-188-2011;
 
21) Kent GL Sow Keymix - Low Salt/High Lysine, Product #2289, bulk feed. Recall # V-189-2011;
 
22) Kent Swine Keymix 30 PT, Product #2291, bulk feed. Recall # V-190-2011;
 
23) Kent X-Tra-Lean Keymix 30 PT, Product #2292, packaged in 50-lb. bag and in bulk. Recall # V-191-2011;
 
24) Kent Swine Key-FLO, Product #2294, bulk feed. Recall # V-192-2011;
 
25) Kent X-Tra-Lean Keymix, Product #2297, packaged in 50-lb. bags. Recall # V-193-2011;
 
26) Kent Swine Keymix, Product #2298, packaged in 50-lb. bags and in bulk. Recall # V-194-2011;
 
27) Kent TechStart Easy Wean ASP250 Medicated, Product #2301, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine, and 50 g/ton penicillin (from procaine penicillin), packaged in 50-lb. bags. Recall # V-195-2011;
 
28) Kent TechStart Easy Wean M50 Medicated, Product #2303, containing 0.0055% (50 g/ton) carbadox, bulk feed. Recall # V-196-2011;
 
29) Kent TechStart Easy Wean, Product #2305, packaged in 50-lb. bags. Recall # V-197-2011;
 
30) Kent TechStart Easy Wean NT800 Medicated, Product #2306, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-198-2011;
 
31) Kent GM Pig Dash, Product #2307, packaged in 50-lb. bags. Recall # V-199-2011;
 
32) Kent TechStart Easy Wean D-CTC400 Medicated, Product #2308, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags and in bulk. Recall # V-200-2011;
 
33) Kent 16% Pig Gold T40 Medicated, Product #2309, containing 40 g/ton tylosin, packaged in 50-lb. bags. Recall # V-201-2011;
 
34) Kent TechStart Mini Nuggets M50 Medicated, Product #2311, containing 0.0055% (50 g/ton) carbadox, packaged in 50-lb. bags. Recall # V-202-2011;
 
35) Kent TechStart Mini Nuggets D-CTC400 Medicated, Product #2314, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-203-2011;
 
36) Kent Pork 40 Plus Supplement, Product #2325, packaged in 50-lb. bags and in bulk. Recall # V-204-2011;
 
37) Kent Flav-R-Ized 20% Pig Nuggets, Product #2332, packaged in 50-lb. bags and in bulk. Recall # V-205-2011;
 
38) Kent Pork 40 Supplement, Product #2333, packaged in 50-lb. bags and in bulk. Recall # V-206-2011;
 
39) Kent Flav-R-Ized 20% Pig Nuggets ASP250 Medicated, Product #2334, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine, and 50 g/ton penicillin (from procaine penicillin), packaged in 50-lb. bags and in bulk. Recall # V-207-2011;
 
40) Kent Flav-R-Ized 20% Pig Nuggets M50 Medicated, Product #2338, containing 0.0055% (50 g/ton) carbadox, packaged in 50-lb. bags and in bulk. Recall # V-208-2011;
 
41) Kent Flav-R-Ized 20% Pig Nuggets D-CTC400 Medicated, Product #2343, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags and in bulk. Recall # V-209-2011;
 
42 Kent Flav-R-Ized 20% Pig Nuggets L200 Medicated, Product #2344, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags and in bulk. Recall # V-210-2011;
43) Kent Flav-R-Ized 20% Pig Nuggets NT800 Medicated, Product #2345, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-211-2011;
44) Kent 18% Golden Nuggets M50B Medicated, Product #2362, containing 0.0055% (50 g/ton) carbadox and 0.0106% pyrantel tartrate, packaged in 50-lb. bags. Recall # V-212-2011;
45) Kent 18% Golden Nuggets ASP250 Medicated, Product #2363, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine, and 50 g/ton penicillin (from procaine penicillin), packaged in 50-lb. bags and in bulk. Recall # V-213-2011;
46) Kent 18% Golden Nuggets M50 Medicated, Product #2364, containing 0.0055% (50 g/ton) carbadox, packaged in 50-lb. bags and in bulk. Recall # V-214-2011;
47) Kent 18% Golden Nuggets L200 Medicated, Product #2365, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-215-2011;
48) Kent 18% Golden Nuggets, Product #2366, packaged in 50-lb. bags and in bulk. Recall # V-216-2011;
49) Kent 18% Golden Nuggets NT800 Medicated, Product #2369, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-217-2011;
50) Kent MED-I-KENT GM T-1.6 Medicated, Product #2372, containing 1.6 g/lb. (3,200 g/ton) tylosin, packaged in 50-lb. bags. Recall # V-218-2011;
 
51) Kent MED-I-KENT GM CTC-8 Medicated, Product #2373, containing 8 g/lb (16,000 g/ton) chlortetracycline, packaged in 50-lb. bags. Recall # V-219-2011;
 
52) Kent 18% Golden Nuggets D-CTC400 Medicated, Product #2374, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-220-2011;
 
53) Kent MED-I-KENT GM L-8 Medicated, Product #2376, containing 8 g/lb (16,000 g/ton) lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-221-2011;
 
54) Kent MED-I-KENT GM D-1.4 Medicated, Product #2378, containing 1.4 g/lb. (2,800 g/ton) tiamulin (as hydrogen fumarate), packaged in 50-lb. bags. Recall # V-222-2011;
 
55) Kent MED-I-KENT GM BMD-5 Medicated, Product #2384, containing 5 g/lb (10,000 g/ton) bacitracin methylene disalicylate, packaged in 50-lb. bags. Recall # V-223-2011;
 
56) Kent MED-I-KENT GM Ivomec Medicated, Product #2386, containing 144 g/ton ivermectin, packaged in 50-lb. bags. Recall # V-224-2011;
 
57) Kent MED-I-KENT GM Micro-Aid, Product #2387, packaged in 50-lb. bags. Recall # V-225-2011;
 
58) Kent ISL, Product #2392, packaged in 50-lb. bags. Recall # V-226-2011;
 
59) Kent Prime Pork, Product #2393, bulk feed. Recall # V-227-2011;
 
60) Kent XTL Prime Pork NP, Product #2398, packaged in 50-lb. bags. Recall # V-228-2011;
 
61) Kent TechStart Mixer 300 NP, Product #2410, packaged in 50-lb. bags. Recall # V-229-2011;
 
62) Kent Golden Nugget Concentrate, Product #2412, packaged in 50-lb. bags and in bulk. Recall # V-230-2011;
 
63) Kent TechStart Mixer 300, Product #2413, packaged in 50-lb. bags and in bulk. Recall # V-231-2011;
 
64) Kent TechStart Mixer 300 ZO, Product #2414, packaged in 50-lb. bags and in bulk. Recall # V-232-2011;
 
65) Kent TechStart Mixer 400, Product #2416, packaged in 50-lb. bags. Recall # V-233-2011;
 
66) Kent TechStart Mixer 400 ZO, Product #2417, packaged in 50-lb. bags. Recall # V-234-2011;
 
67) Kent 16% Pork Maker UM, Product #2419, packaged in 50-lb. bags. Recall # V-235-2011;
 
68) Kent Tech Start 25-40, Product #2421, packaged in 50-lb. bags and in bulk. Recall # V-236-2011;
 
69) Kent TechStart 25-40 ASP250 Medicated, Product #2422, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine, and 50 g/ton penicillin (from procaine penicillin), packaged in 50-lb. bags. Recall # V-237-2011;
 
70) Kent TechStart 25-40 D-CTC400 Medicated, Product #2424, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-238-2011;
 
71) Kent 12% Pork Finisher UM, Product #2429, bulk feed. Recall # V-239-2011;
 
72) Kent TechStart 17-25, Product #2431, packaged in 50-lb. bags and in bulk. Recall # V-240-2011;
 
73) Kent TechStart 17-25 ASP250 Medicated, Product #2432, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine, and 50 g/ton penicillin(from procaine penicillin), packaged in 50-lb. bags and in bulk. Recall # V-241-2011;
 
74) Kent TechStart 17-25 D-CTC400 Medicated, Product #2434, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags and in bulk. Recall # V-242-2011;
 
75) Kent TechStart 17-25 NT800 Medicated, Product #2438, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-243-2011;
 
76) Kent TechStart 17-25 M50 Medicated, Product #2439, containing 0.0055% carbadox, packaged in 50-lb. bags and in bulk. Recall # V-244-2011;
 
77) Kent TechStart 12-17 D-CTC400 Medicated, Product #2441, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags and in bulk. Recall # V-245-2011;
 
78) Kent TechStart 12-17 ASP250 Medicated, Product #2442, containing 100 g/ton chlortetracycline, 0.011% sulfamethazine and 50 g/ton penicillin (from procaine penicillin), packaged in 50-lb. bags and in bulk. Recall # V-246-2011;
 
79) Kent TechStart 12-17, Product #2444, packaged in 50-lb. bags and in bulk. Recall # V-247-2011;
 
80) Kent TechStart 12-17 M50 Medicated, Product #2445, containing 0.0055% (50 g/ton) carbadox, packaged in 50-lb. bags and in bulk. Recall # V-248-2011;
 
81) Kent Ulti-Lact 367 Half Lax, Product #2450, bulk feed. Recall # V-249-2011;
 
82) Kent 16% Pig Gold CTC100 Medicated, Product #2459, containing 100 g/ton chlortetracycline, packaged in 50-lb. bags. Recall # V-250-2011;
 
83) Kent 14% Pork Maker BMD Medicated, Product #2479, containing 30 g/ton bacitracin methylene disalicylate, packaged in 50-lb. bags. Recall # V-251-2011;
 
84) Kent KS Swine Premix, Product #2491, packaged in 50-lb. bags and in bulk. Recall # V-252-2011;
 
85) Kent GL X-TRA, Product #2493, packaged in 50-lb. bags. Recall # V-253-2011;
 
86) Kent 14% Pork Maker UM, Product #2519, packaged in 50-lb. bags. Recall # V-254-2011;
 
87) Kent X-Tra-Lean 18 KNT/Integral, Product #2568, packaged in 50-lb. bags. Recall # V-255-2011;
 
88) Kent X-Tra-Lean 18, Product #2569, packaged in 50-lb. bags and in bulk. Recall # V-256-2011;
 
89) Kent X-Tra-Lean 18 BI, Product #2570, packaged in 50-lb. bags. Recall # V-257-2011;
 
90) Kent Pre-Stardom D-CTC400 Medicated, Product #2603, containing 35 g/ton tiamulin (as hydrogen fumarate) and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-258-2011;
 
91) Kent Stardom D-CTC400 Medicated, Product #2609, containing 35 g/ton tiamulin (as hydrogen fumarate) and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags and in bulk. Recall # V-259-2011;
 
92) Kent Stardom, Product #2610, bulk feed. Recall # V-260-2011;
 
93) Kent Stardom L200 Medicated, Product #2611, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-261-2011;
 
94) Kent Stardom Mixer, Product #2613, packaged in 50-lb. bags and in bulk. Recall # V-262-2011;
 
95) Kent Stardom Mixer 500, Product #2614, packaged in 50-lb. bags. Recall # V-263-2011;
 
96) Kent Max-E-Cal 26, Product #2615, bulk feed. Recall # V-264-2011;
 
97) Kent X-Tra-Lean 433, Product #2621, packaged in 50-lb. bags and in bulk. Recall # V-265-2011;
 
98) Kent X-Tra-Lean 418, Product #2622, packaged in 50-lb. bags. Recall # V-266-2011;
 
99) Kent Commercial 38 NP, Product #2627, bulk feed. Recall # V-267-2011;
 
100) Kent Commercial 42, Product #2628, packaged in 50-lb. bags and in bulk. Recall # V-268-2011;
 
101) Kent Commercial 407, Product #2631, bulk feed. Recall # V-269-2011;
 
102) Kent Commercial 43PT, Product #2632, bulk feed. Recall # V-270-2011;
 
103) Kent X-Tra-Lean 38 NP, Product #2633, bulk feed. Recall # V-271-2011;
 
104) Kent Show Pig Base Mix, Product #2636, packaged in 50-lb. bags. Recall # V-272-2011;
 
105) Kent Conditioner, Product #2640, packaged in 50-lb. bags. Recall # V-273-2011;
 
106) Kent Conditioner L100 Medicated, Product #2641, containing 100 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-274-2011
 
107) Kent Conditioner L200 Medicated, Product #2644, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-275-2011;
 
108) Kent Hands Down, Product #2690, packaged in 50-lb. bags. Recall # V-276-2011;
 
109) Kent Hands Down L200 Medicated, Product #2691, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-277-2011;
 
110) Kent Hands Down L100 Medicated, Product #2692, containing 100 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-278-2011;
 
111) Kent Show Pig Supplement, Product #2745, packaged in 50-lb. bags. Recall # V-279-2011;
 
112) Kent Prime Time L100 Medicated, Product #2752, containing 100 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-280-2011;
 
113) Kent Prime Time Plus Medicated, Product #2754, containing 9 g/ton ractopamine hydrochloride, packaged in 50-lb. bags. Recall # V-281-2011;
 
114) Kent Prime Time L200 Medicated, Product #2755, containing 200 g/ton lincomycin (as lincomycin hydrochloride), packaged in 50-lb. bags. Recall # V-282-2011;
 
115) Kent Prime Time CTC100 Medicated, Product #2758, containing 100 g/ton chlortetracycline, packaged in 50-lb. bags. Recall # V-283-2011;
 
116) Kent Prime Time T100 Medicated, Product #2759, containing 100 g/ton tylosin, packaged in 50-lb. bags. Recall # V-284-2011;
 
117) Kent Show Pig Power PAK, Product #2760, packaged in 50-lb. bags. Recall # V-285-2011;
 
118) Kent Prime Time Plus T100 Medicated, Product #2762, containing 100 g/ton tylosin and 9 g/ton ractopamine hydrochloride, packaged in 50-lb. bags. Recall # V-286-2011;
 
119) Kent Max-E-Cal Sow 27, Product #2764, packaged in 50-lb. bags. Recall # V-287-2011;
 
120) Kent X-Tra-Cal 40, Product #2768, packaged in 50-lb. bags and in bulk. Recall # V-288-2011;
 
121) Kent Watje Swine 2# VTM, Product #2786, packaged in 50-lb. bags. Recall # V-289-2011;
 
122) Kent Windy Hills Gestation, Product #2799, bulk feed. Recall # V-290-2011;
 
123) Kent Swine 2# VTM, Product #2802, packaged in 50-lb. bags. Recall # V-291-2011;
 
124) Kent SP Mixer 50, Product #2803, packaged in 50-lb. bags. Recall # V-292-2011;
 
125) Kent Gary Teague Sow Base Mix w/Phytase, Product #2809, bulk feed. Recall # V-293-2011;
 
126) Kent SPT, Product #2812, packaged in 50-lb. bags. Recall # V-294-2011;
 
127) Kent SPT + LYS, Product #2813, packaged in 50-lb. bags and in bulk. Recall # V-295-2011;
 
128) Kent SPT DDGS, Product #2814, packaged in 50-lb. bags and in bulk. Recall # V-296-2011;
 
129) Kent SPT + LYS DDGS, Product #2815, packaged in 50-lb. bags and in bulk. Recall # V-297-2011;
 
130) Kent Auburn Swine Base PT, Product #2816, packaged in 50-lb. bags. Recall # V-298-2011;
 
131) Kent SPT Amino Acid Vit D, Product #2818, bulk feed. Recall # V-299-2011;
 
132) Kent Complete Pig and Sow, Product #2819, packaged in 50-lb. bags. Recall # V-300-2011;
 
133) Kent SPT DDGS Amino Acid, Product #2820, bulk feed. Recall # V-301-2011;
 
134) Kent Paris 12-17 D-CTC400, Product #2823, packaged in 50-lb. bags and in bulk. Recall # V-302-2011;
 
135) Kent Clayton Swine G/F, Product #2828, packaged in 50-lb. bags. Recall # V-303-2011;
 
136) Kent Clayton GL, Product #2829, packaged in 50-lb. bags. Recall # V-304-2011;
 
137) Kent HB Starter Base, Product #2831, bulk feed. Recall # V-305-2011;
 
138) Kent Ralphs Feed 42, Product #2845, bulk feed. Recall # V-306-2011;
 
139) Kent Porter Gestation, Product #2847, packaged in 50-lb. bags and in bulk. Recall # V-307-2011;
 
140) Kent Porter 20 Lactation, Product #2848, bulk feed. Recall # V-308-2011;
 
141) Kent Max-E-Cal Farrowing PELS, Product #2849, packaged in 50-lb. bags and in bulk. Recall # V-309-2011;
 
142) Kent JS Show Pig, Product #2850, packaged in 50-lb. bags. Recall # V-310-2011;
 
143) Kent Ralphs Feed 42 NS, Product #2851, bulk feed. Recall # V-311-2011;
 
144) Kent DFI Swine 2# VTM, Product #2853, bulk feed. Recall # V-312-2011;
 
145) Kent Hamilton Coop Sow Base, Product #2854, packaged in 50-lb. bags. Recall # V-313-2011;
 
146) Kent Monroe Swine Base PT, Product #2857, packaged in 50-lb. bags. Recall # V-314-2011;
 
147) Kent Monroe Sow Base, Product #2858, packaged in 50-lb. bags. Recall # V-315-2011;
 
148) Kent Deluxe Sow Base, Product #2863, packaged in 50-lb. bags and in bulk. Recall # V-316-2011;
 
149) Kent Waverly Premix, Product #2866, packaged in 50-lb. bags. Recall # V-317-2011;
 
150) Kent NW Sow Base, Product #2867, bulk feed. Recall # V-318-2011;
 
151) Kent Dan Link Custom, Product #2875, bulk feed. Recall # V-319-2011;
 
152) Kent HB Sow Base Mix PT, Product #2876, bulk feed. Recall # V-320-2011;
 
153) Kent Max-E-Cal Farrowing PELS NT800 Medicated, Product #2878, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-321-2011;
 
154) Kent Complete Easy-Farrow NT800 Medicated, Product #2880, containing 400 g/ton oxytetracycline and 400 g/ton neomycin sulfate, packaged in 50-lb. bags. Recall # V-322-2011;
 
155) Kent CB Hog Concentrate, Product #2883, bulk feed. Recall # V-323-2011;
 
156) Kent SMX PT + LYS, Product #2884, packaged in 50-lb. bags and in bulk. Recall # V-324-2011;
 
157) Kent SMX PT, Product #2885, bulk feed. Recall # V-325-2011;
 
158) Kent SMX + LYS, Product #2886, packaged in 50-lb. bags and in bulk. Recall # V-326-2011;
 
159) Kent SMX, Product #2887, packaged in 50-lb. bags and in bulk. Recall # V-327-2011;
 
160) Kent Swine 6050, Product #2888, packaged in 50-lb. bags and in bulk. Recall # V-328-2011;
 
161) Kent Swine Premix DDGS 6050, Product #2889, bulk feed. Recall # V-329-2011;
 
162) Kent Deluxe SP Mixer 50, Product #2898, packaged in 50-lb. bags and in bulk. Recall # V-330-2011;
 
163) Kent Killduff Swine Base, Product #2901, packaged in 50-lb. bags. Recall # V-331-2011;
 
164) Kent Monroe 20% Starter M50 Medicated, Product #2916, containing 0.0055% (50 g/ton) carbadox, bulk feed. Recall # V-332-2011;
 
165) Kent NW Swine Base, Product #2921, packaged in 50-lb. bags and in bulk. Recall # V-333-2011;
 
166) Kent 20% Pig Starter NP, Product #2926, packaged in 50-lb. bags. Recall # Recall # V-334-2011;
 
167) Kent 36 GM Base NP, Product #2928, packaged in 50-lb. bags and in bulk. Recall # V-335-2011;
 
168) Kent Carrigan 34% Sow Cubes, Product #2930, packaged in 50-lb. bags. Recall # V-336-2011;
 
169) Kent LeMars Base Mix PT, Product #2933, packaged in 50-lb. bags. Recall # V-337-2011;
 
170) Kent SMX DDGS, Product #2937, packaged in 50-lb. bags. Recall # V-338-2011;
 
171) Kent SMX PT DDGS, Product #2939, bulk feed. Recall # V-339-2011;
 
172) Kent SMX PT + DDGS, Product #2940, bulk feed. Recall # V-340-2011;
 
173) Kent Golden Nugget Concentrate NP, Product #2941, packaged in 50-lb. bags. Recall # V-341-2011;
 
174) Kent Pig Nugget Mixer NP, Product #2943, packaged in 50-lb. bags. Recall # V-342-2011;
 
175) Kent Cooper 34% Sow Cubes, Product #2944, packaged in 50-lb. bags. Recall # V-343-2011;
 
176) Kent Hi Fat Sow Cubes, Product #2952, packaged in 50-lb. bags. Recall # V-344-2011;
 
177) Kent KF Stress Diet, Product #2960, packaged in 50-lb. bags. Recall # V-345-2011;
 
178) Kent G X-TRA DDG, Product #2961, packaged in 50-lb. bags. Recall # V-346-2011;
 
179) Kent Klostermann Sow Base, Product #2962, packaged in 50-lb. bags. Recall # V-347-2011;
 
180) Kent Flav-R-Ized 20% Pig Nuggets D-CTC400 EZn Medicated, Product #2964, containing 35 g/ton tiamulin hydrogen fumarate and 400 g/ton chlortetracycline calcium complex equivalent to chlortetracycline HCl, packaged in 50-lb. bags. Recall # V-348-2011;
 
181) Kent Klostermann Swine Base PT, Product #2966, packaged in 50-lb. bags. Recall # V-349-2011;
 
182) Kent X-Tra-Lean Keymix 30 PT DDGS, Product #2969, packaged in 50-lb. bags and in bulk. Recall # V-350-2011;
 
183) Kent PMX PT + LYS, Product #2972, bulk feed. Recall # V-351-2011;
 
184) Kent PMX, Product #2974, bulk feed. Recall # V-352-2011;
 
185) Kent Waverly Coop Premix + Lys, Product #2980, packaged in 50-lb. bags. Recall # V-353-2011;
 
186) Kent SMX NP, Product #2982, packaged in 50-lb. bags. Recall # V-354-2011;
 
187) Kent SMX + LYS NP, Product #2984, packaged in 50-lb. bags. Recall # V-355-2011;
 
188) Kent Pork G/F Pmx, Product #2988, packaged in 60-lb. bags. Recall # V-356-2011;
 
189) Kent Prime Pork NP, Product #2997, packaged in 50-lb. bags and in bulk. Recall # V-357-2011;
 
190) Kent First Rate Swine Dewormer Medicated, Product #8142, containing 0.0054% (24.5 mg/lb) fenbendazole, packaged in 25-lb. bags. Recall # V-358-2011;
 
191) Kent First Rate Swine Dewormer Medicated, Product #8156, containing 0.0054% (24.5 mg/lb) fenbendazole, packaged in 50-lb. bags. Recall # V-359-2011;
 
192) Kent First Rate Hang Time, Product #8516, packaged in 25-lb. bags. Recall # V-360-2011;
 
193) Kent First Rate Final Drive, Product #8522, packaged in 25-lb. bags. Recall # V-361-2011;
 
194) Kent First Rate Overdrive PL450, Product #8523, containing 450 g/ton ractopamine hydrochloride, packaged in 25-lb. bags. Recall # V-362-2011
CODE
All products coded 09335 through 09365 and 10001 through 10158
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kent Feeds, Inc., Muscatine, IA, by telephone on June 16, 2010, letters dated June 15, 2010 and by press release on June 17, 2010.
Manufacturers: Kent Feeds Inc., Altoona, IA;
Kent Feeds Inc., Sioux City, IA;
Kent Feeds Inc., Waterloo, IA;
Kent Feeds Inc., Columbus, NB;
Kent Feeds Inc., Marshall, MO;
Kent Feeds Inc., Logansport, IN;
Kent Feeds, Inc., Mason, MI;
Kent Feeds Inc., Louisville, KY;
Kent Feeds Inc., Beardstown, IL;
Kent Feeds Inc., Rockford, IL.
Firm initiated recall is complete.
REASON
Some of the vitamin premix used in the finished swine feed contains insufficient levels of Vitamin D.
VOLUME OF PRODUCT IN COMMERCE
Approx. 18,616,191 tons
DISTRIBUTION
AR, CO, IA, IL, IN, KS, KY, MI, MN, MO, ND, NE, OH, OK, SD, TN, TX, WI, and WV
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
1) Pfizer TM Crumbles Medicated; Active Drug ingredient - Oxytetracycline 2 grams/LB; a medicated feed designed to be fed to pullets and broiler chickens, turkeys, sheep, swine, beef cattle and lobsters; 50 lb. bag; item 4574-M FL 0501, UPC 7 22304 01294 6. Recall # V-363-2011;
 
2) Country Lane Meat Goat Developer (FL); an animal feed in pellet form designed to be fed to all classes of goats; 40 lb. bag; item 33039 FL 0810, UPC 7 22304 20425 9. Recall # V-364-2011;
 
3) Nutrena Naturewise Goat Textured 17% (FL); an animal feed in pellet form designed to be fed to growing, breeding and lactating goats; 50 lb. bag; item 91700 FL 0810, UPC 7 22304 03155 8. Recall # V-365-2011
CODE
1) Lot numbers: FL 1052, FL 1061, FL 1089 and FL 1103;
2) Lot numbers: FL 1061, FL 1062, FL 1076 and FL 1087;
3) Lot numbers: FL 1056, FL 1059, FL 1090 and FL 1100;
RECALLING FIRM/MANUFACTURER
Cargill Animal Nutrition, Flora, IL, by telephone on May 17, 2011. Firm initiated recall is complete.
REASON
The ruminant feeds were manufactured with yellow grease with more than 0.15% insoluble impurities, and non-ruminant feeds manufactured with the same yellow grease lacked the caution statement "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
53,225 tons
DISTRIBUTION
AR, IL, IN, KY, MO, and TN
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT
1) Nutrena Porktrack Hog Finisher Concentrate 40% (FL); an animal feed in pellet form designed to be fed to growing and finishing hogs weighing from 22 lb bodyweight to market weight; 50 lb. bag; item 90647 FL 1104, UPC 7 22304 05886 9. Recall # V-366-2011;
 
2) Country Lane 16% Hog Grower Pellets (C100) (FL) Medicated; Chlortetracycline 100 grams/ton; a medicated feed in pellet form designed to be fed to growing pigs through finish; 50 lb. bag; item 33021-A FL 0810, UPC 7 22304 00167 0. Recall # V-367-2011;
 
3) 18% Pig Starter (C50) (FL) Medicated; Chlortetracycline 50 grams/ton; a medicated feed in pellet form designed to be fed to pigs from Minneapolis, MN to 110 lbs bodyweight; 50 lb. bag; item 1750-C FL 1105, UPC 7 22304 03620 1. Recall # V-368-2011
CODE
1) Lot number: FL 1116;
2) Lot numbers: FL 1047, FL 1056, FL 1061, FL 1083, FL 1102 and FL 11292);
3) Lot numbers: FL 1063, FL 1068 and FL 1099
RECALLING FIRM/MANUFACTURER
Cargill Animal Nutrition, Flora, IL, by telephone on May 17, 2011. Firm initiated recall is complete.
REASON
The ruminant feeds were manufactured with yellow grease with more than 0.15% insoluble impurities, and non-ruminant feeds manufactured with the same yellow grease lacked the caution statement "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
53,225 tons
DISTRIBUTION
AR, IL, IN, KY, MO, and TN
 
END OF ENFORCEMENT REPORT FOR JULY 6, 2011
 
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