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U.S. Department of Health and Human Services

Enforcement Report - Week of October 15, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Guinea Pig Diet PMI NUTRITION INTL., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144 Net Weight 50 Ib (22.67 kg) All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive Formula No. 5025 Item Number. 0001330 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X) PMI Nutrition International
Veterinary MAZURI MANED WOLF DIET THE RICHMOND STANDARD PMI NUTRITION INT'l., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144-6812 15kg APR21122, Formula No. 5MD9, Item No. 0011482. Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X) PMI Nutrition International
Veterinary MAZURI SMALL BIRD MAINTENANCE PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144·6812 Net Weight 251b (11.33 kg) APR15123, Formula No. 56A6, Item No. 0001452. Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X) PMI Nutrition International
Veterinary Mazuri Primate Maintenance Biscuit PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144·6812 Net Weight 251b (11.33 kg) APR11123 Formula No. 5MA2 Item No. 0040996 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). PMI Nutrition International
Veterinary Mazuri Mouse Breeder 9F, FOR BREEDING RODENTS CAUTION: USE AS DIRECTED, PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144·6812 Net. Weight 50 Ib (22.67 kg) APR20122PMI Formula No. 5M68 Item No. 0006758 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). PMI Nutrition International
Veterinary MAZURI PRIMATE BASIX, FOR PRIMATES ~ CAUTION: USE ONLY AS DIRECTED, PMI NUTRITION INT'L., LLC. P.O. BOX 19798, BRENTWOOD, MO 63144·6812 Net. Weight 25 Ib (11.33 kg) APR20122PMI FORMULA NO. 5M68 ITEM NO. 0006758 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). PMI Nutrition International
Veterinary MAZURI EX GAMEBIRD STARTER 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5637 ITEM NO. 0001430 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100X). PMI Nutrition International
Veterinary MONKEY DIET JUMBO 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5037 ITEM NO. 0001332 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5038 ITEM NO. 0001333 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary NEW WORLD PRIMATE DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5040 ITEM NO. 0001334 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HIGH PROTEIN MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5045 ITEM NO. 0001335 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HIGH PROTEIN MONKEY DIET JUMBO 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5047 ITEM NO. 0001336 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary CERTIFIED GUINEA PIG DIET 33 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5026 ITEM NO. 0002032 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary CERTIFIED PRIMATE DIET 22 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5048 ITEM NO. 0005325 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary LAB FIBERPLUS MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5049 ITEM NO. 0005326 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary LAB FIBERPLUS MONKEY DIET JUMBO 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5050 ITEM NO. 0005328 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AUTOCLAVABLE RODENT BREEDER DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5013 ITEM NO. 0006529 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary GUINEA PIG DIET 33 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5025 ITEM NO.0006544 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HIGH PROTEIN MONKEY DIET JUMBO 25LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5047 ITEM NO.0006554 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary LAB FIBER PLUS MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5K63 ITEM NO.0006669 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PMI CERTIFIED HI FIBER PRIMATE JUMBO 22 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5K91 ITEM NO.0006684 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PMI LAB FIBERPLUS MONKEY DIET 15% 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L07 ITEM NO.0006690 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary RODENT LAB DIET EQ 44.1 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L37 ITEM NO.0006705 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary RODENT LAB AUTO DIET EQ 20 KG All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L65 ITEM NO.0006712 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary FIBER PLUS MONKEYPNT 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LB2 ITEM NO.0006746 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PROLAB RMH 2500 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P14 ITEM NO.0006788 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PROLAB RMH 2500 15 KG All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P14 ITEM NO.0055648 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PROLAB GUINEA PIG 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5P18 ITEM NO.0006791 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PMI LAB FIBERPLUS MONKEY 20JUMBO 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L0K ITEM NO.0007532 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary FIBER ENHANCER 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 56DJ ITEM NO.0010748 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary TAD PRIMATE DIET 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L0P ITEM NO.0011746 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MONKEY DIET 15% 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LE0 ITEM NO.0015349 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PROLAB RMH 1800 AUTOCLAVABLE 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5013 ITEM NO.0029432 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary ISOPRO RHM 2500 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LN6 ITEM NO.0047063 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary LAB FIBERPLUS MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5CAM ITEM NO.0047230 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary NIA GERIATRIC PRIMATE DIET 22 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5L1F ITEM NO.0049716 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary PROLAB RMH 1800 33 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5LL2 ITEM NO.0051209 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary GUINEA PIG DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5025 ITEM NO.0057230 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HIGH PROTEIN MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5045 ITEM NO.0057231 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary FIBERBALANCED MONKEY JUMBO 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5000 ITEM NO.0062306 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HF PRIMATE 5K91 12G 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5K9J ITEM NO.0065046 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MONKEY DIET JUMBO 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5LFD ITEM NO.0066782 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary CU ADULT FROG DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z18 ITEM NO.0006841 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary CU JUVENILE FROG DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z49 ITEM NO.0006848 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Mazuri CRL GUINEA PIG AUTO, W/O VIT C 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5KG0 ITEM NO.0066196 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary 5LK7 / 20000 IU/KG VIT D3 (Weight VARIES) 12APR24RTD1 One Lot Only FORMULA NO.9G4P ITEM NO.1815328 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX GROWER 600 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D06 ITEM NO.0001468 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina CATFISH 32 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.51J2 ITEM NO.0040967 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina CATFISH CHOW SR 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5136 ITEM NO.0007136 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZ KOI POND NUGGETS 20 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5M78 ITEM NO.0001489 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI GUINEA PIG DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5664 ITEM NO.0001444 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI RATITE DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5647 ITEM NO.0001437 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI WATERFOWL MAINT. 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5642 ITEM NO.0001435 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary NUTRISOURCE KOI POND 4.25 LB Best If Used By 04/25/14 FORMULA NO.5ZC9 ITEM NO.0049071 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina WELLSOLVE W/C 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.35TD ITEM NO.0066925 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI KOI PLATINUM NUGGETS 20 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5M80 ITEM NO.0001491 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX GROWER 400 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D04 ITEM NO.0001466 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX GROWER 500 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D05 ITEM NO.0045303 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX POND 2000 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.5D07 ITEM NO.0001469 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina GAME FISH CHOW 50 LB All Lots APR 02 12 1 thru MAY 08 12 12 3 Inclusive FORMULA NO.52C1 ITEM NO.0001363 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI LEAF EATER PRIMATE DIET MINI-BISCUIT 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5672 ITEM NO.0001448 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PARROT MAINTENANCE 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56A8 ITEM NO.0001454 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PARROT BREEDER 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56A9 ITEM NO.0001455 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX DENSE 4000 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D09 ITEM NO.0001470 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI LEAF EATER PRIMATE DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M02 ITEM NO.0001472 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI MONKEY CRUNCH 20 20 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M29 ITEM NO.0001476 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI RODENT 6F 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M30 ITEM NO.0001477 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI RATITE STARTER 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M32 ITEM NO.0001480 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PLATINUM KOI BITS 20 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M81 ITEM NO.0001492 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI KANGAROO & WALLABY DIET 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z88 ITEM NO.0001500 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PETTING ZOO 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z95 ITEM NO.0001504 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI FLAMINGO COMPLETE 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5644 ITEM NO.0005480 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI FLAMINGO BREEDER 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5645 ITEM NO.0005482 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CRANE DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5646 ITEM NO.0005484 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI MOOSE MAINTENANCE 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5658 ITEM NO.0005501 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI ZEBRA PELLETS 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5662 ITEM NO.0005506 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX FRY STARTER 200 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D02 ITEM NO. 0005554 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX FINGERLING 300 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D03 ITEM NO. 0005555 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina Minnow Chow 50# 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5115 ITEM NO. 0006569 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI FLAMINGO BREEDER 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5645 ITEM NO. 0006593 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI MOUSE 11F 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M99 ITEM NO. 0006763 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI GUINEA PIG BREEDER 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z19 ITEM NO. 0006842 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI HERBIVORE BOOST 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5Z0D ITEM NO. 0006992 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI HIGH FIBER STICKS 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA3 ITEM NO. 0007316 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PRIMATE BROWSE BISCUIT 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA4 ITEM NO. 0007317 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI NEW WORLD PRIMATE 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA5 ITEM NO. 0007320 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI GROWTH & REPRO PRIMATE BISCUIT 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MA1 ITEM NO. 0007321 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX FRY POWDER 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D00 ITEM NO. 0007684 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX POND PLUS 3000 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D08 ITEM NO.0007685 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI KOI PLAT OGATA 20 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MC8 ITEM NO.0007687 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary EH GUINEA PIG DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5L1P ITEM NO.0037461 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary ORNAMENTAL FISH GROWER 3/16 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D18 ITEM NO.0038282 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX GROWER 5/8 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D1D ITEM NO.0038854 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AUTOCLAVABLE RODENT BREEDER DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5013 ITEM NO.0042048 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX CUSTOM 41/12 3/16 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D2L ITEM NO.0042091 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX CUSTOM 41/12 1/8 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D2N ITEM NO.0042092 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PRIMATE L/S BANANA 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M1G ITEM NO.0043252 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI TIMOTHY RABBIT DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.530Q ITEM NO.0043945 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary Purina WellSolve W/G 25# (bucket) 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.35SU ITEM NO.0046451 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI FRESH WATER TURTLE DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5M87 ITEM NO.0047362 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary KOI KICHI COLOR ENHANCER 40# 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D55 ITEM NO.0047481 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CALLITRICHID GEL NO ADD SUGAR (SIZE VARIES) 12MAY04RTD1 One Lot Only FORMULA NO.592Y ITEM NO.0047797 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary ORNAMENTAL FISH GROWER 1/8 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D57 ITEM NO.0049312 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI INSECTIVORE DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MK8 ITEM NO.0050819 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary KOI KICHI WHEAT GERM FOOD 40# 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D58 ITEM NO.0051044 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI PARROT BREEDER 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MI8 ITEM NO.0052901 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX GROWER NAB 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5D23 ITEM NO.0053713 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary GUINEA PIG DIET 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5025 ITEM NO.0057230 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary HIGH PROTEIN MONKEY DIET 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5045 ITEM NO.0057231 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI KOI PLATINUM - WHEAT NUGGETS 20 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.50D0 ITEM NO.0060561 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary EVANS FIBER NUTRIENTS 25 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.56CC ITEM NO.0061020 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CROCODILIAN DIET - LARGE 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG2 ITEM NO.0062645 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CU TX RODENT 6F 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG3 ITEM NO.0063538 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary CU CARNIVORE TURTLE 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.L539 ITEM NO.0063712 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI FLAMINGO COMPLETE 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5MG6 ITEM NO.0064874 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI BEAR DIET 40 LB APR 09 12 3 One lot Only FORMULA NO.5ZH6 ITEM NO.0064966 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CU RODENT BRDR GA 9F 50 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5LU2 ITEM NO.0065748 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary AQUAMAX LARGEMOUTH 40 LB All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO.5DA1 ITEM NO.0066904 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CALLITRICHID GEL HEAT STABLE (SIZE VARIES) 12MAY14RTD1 One Lot Only FORMULA NO.57R0 ITEM NO.1810111 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI BROOKFIELD ZOO CALLITRICHID DIET (SIZE VARIES) 12MAY10RTD1 One Lot Only FORMULA NO.5TAF ITEM NO.1810536 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZURI CALLITRICHID GEL DIET, PLUS (SIZE VARIES) 12MAY11RTD1 One Lot Only FORMULA NO.5B33 ITEM NO.1815097 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Veterinary MAZ CU FRZ CALL HI D (SIZE VARIES) 12APR20RTD1 One Lot Only FORMULA NO.5BOU ITEM NO.1815310 All Lots APR 02 12 1 thru MAY 08 12 3 Inclusive FORMULA NO. 5646 ITEM NO.0005484 Class I Four customer complaints received. One customer reported mortality of 7 parakeets and one customer reported mortality of 14 small birds. Veterinarian diagnosis on two of the complaints indicated vitamin D toxicity. Analysis of two plant retained samples found an elevated levels of vitamin D (100 X). PMI Nutrition International
Biologics Plasma Frozen within 24 hours (FP24) W286812007756 W286812007784 W286812008916 W286812008918 W286812008919 W286812008922 W286812008928 W286812008932 W286812008933 W286812008934 W286812008935 W286812008937 W286812008938 W286812008943 W286812008946 W286812008949 W286812010334 W286812010368 W286812011785 W286812011786 W286812011789 W286812011794 W286812011796 W286812011797 W286812011803 W286812011816 W286812011824 W286812011838 W286812011839 W286812011845 W286812011850 W286812011851 W286812013115 W286812013118 W286812013119 W286812015624 W286812015809 W286812015824 W286812015855 W286812016186 W286812016187 W286812016190 W286812016191 W286812016193 W286812016197 W286812016198 W286812016199 W286812016204 W286812016205 W286812016219  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Fresh Frozen Plasma W286812007434 W286812011822 W286812013183 W286812016214 W286812016218 W286812024764 W286812029439 W286812029446 W286812029452 W286812029952 W286812035363 W286812075312 W286813008423 W287912004596 Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Cryoprecipitated AHF W286812007416; W286812007418; W286812007421; W286812007424; W286812007425; W286812007426; W286812007427; W286812007708; W286812007431; W286812007432; W286812007436; W286812007437; W286812007438; W286812007439; W286812000675; W286812000679; W286812000680; W286812000684; W286812001061; W286812007723; W286812007733; W286812007806; W286812007811; W286812007813; W286812007814; W286812007815; W286812008951; W286812011840; W286812016195; W286812016210; W286812016213; W286812019728; W286812020332; W286812024550; W286812024552; W286812024760; W286812024771; W286812026300; W286812026952; W286812026959; W286812026964; W286812026966; W286812026968; W286812026971; W286812027075; W286812027960; W286812027971; W286812029421; W286812029422; W286812029427;  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Blood and Blood Products for Reprocessing W286812007756 W286812007784 W286812008916 W286812008918 W286812008919 W286812008922 W286812008928 W286812008932 W286812008933 W286812008934 W286812008935 W286812008937 W286812008938 W286812008943 W286812008946 W286812008949 W286812010334 W286812010368 W286812011785 W286812011786 W286812011789 W286812011794 W286812011796 W286812011797 W286812011803 W286812011816 W286812011824 W286812011838 W286812011839 W286812011845 W286812011850 W286812011851 W286812013115 W286812013118 W286812013119 W286812015624 W286812015809 W286812015824 W286812015855 W286812016186 W286812016187 W286812016190 W286812016191 W286812016193 W286812016197 W286812016198 W286812016199 W286812016204 W286812016205 W286812016219  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W286813000292 W286813000292 W286813000320 W286813000320 W286813001209 W286813001209 W286813001237 W286813001237 W286813001248 W286813001248 W286813001269 W286813001271 W286813001271 W288212003672 W288212003672 Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Red Blood Cells (Human) (Blood and Blood Derivatives) W286812079936 W286812082981 W286812084316 W286812084331 W286812084345 W286812084347 W286812084350 W286812084400 W286812084401 W286812112123 W286812113492 W286812113519 W286812113521 W286812116301 W286812116319 W286812120414 W286812120418 W286812120442 W286812120447 W286812125931 W286812125934 W286812127094 W286812127103 W286812127107 W286812127200 W286813000275 W286813000287 W286813000295 W286813000305 W286813000307 W286813000310 W286813000323 W286813000325 W286813000329 W286813001201 W286813001205 W286813001206 W286813001214 W286813001215 W286813001229 W286813001233 W286813001241 W286813001251 W286813001258 W286813001259 W286813001265 W286813001274 W286813001276 W286813001425 W286813003279  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Red Blood Cells (Human) Leukocytes Removed (Blood and Blood Derivatives) W286812079933 W286812079934 W286812079939 W286812079941 W286812079943 W286812079947 W286812079951 W286812079961 W286812079962 W286812113496 W286812113499 W286812113518 W286812113522 W286812116297 W286812116303 W286812116310 W286812116318 W286812120423 W286812120445 W286812120863 W286812125909 W286812125910 W286812125911 W286812125912 W286812125914 W286812125915 W286812125917 W286812125921 W286812125923 W286812125924 W286812125925 W286812125927 W286812125928 W286812125930 W286812125935 W286812125936 W286812125937 W286812125940 W286812125943 W286812125945 W286812125946 W286812125949 W286812125950 W286812125951 W286812125953 W286812125954 W286812125958 W286812125960 W286812125961 W286812125962  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Cryoprecipitated AHF, Pooled W383812000010 W383812000118 W383812000126 W383812000183 W383812000184 W383812000185 W383812000189 W383812000256 W383812000262 W383812000269 W383812000270 W383812000271 W383812000272 W383812000425 W383812000463 W383812000464 W383812000474 W383812000605 W383812000716 W383812000727 W383812000738 W383812000745 W383812000749 W383812000762 W383812000774 W383812000775 W383812000777 W383812000831 W383812000839 W383812000840 W383812000879 W383812001022 W383812001061 W383812001279 W383812001335 W383812001336 W383812001371 W383812001519 W383812001534 W383812001600 W383812001643 W383812001646 W383812001656 W383812001798 W383812001799 W383812001894 W383812002089 W383812002129 W383812002264 W383812002332  ...
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Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Platelets Pheresis W286812024558; W286812026300; W286812029459; W286812029461; W286812029467; W286812029471; W286812029476; W286812029950 Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Biologics Red Blood Cells Leukocytes Reduced Irradiated W286812125916; W286812125942 Class II Blood products, collected from unsuitable donors, were distributed. LifeSource
Devices ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. 01516 , P0106045 , P0106415 , P0106416 , P0106417    , P0107780 , P0108277 , P0108715 , P0108716 , P0108717 , P0109782 , P0109783 , P0109954 , P0110233 , P0111026 , P0111276 , P0111872 , P0111873 , P0112155 , P0112156 , P0112157 , P0112158 , P0112955 , P0113151 , P0113364 , P0115133 , P0115301 , P0115302 , P0116051 , P0116614 , P0116615 , P0117468 , P0117880 , P0117881 , P0122188 , P0122460 , P0125766 , P0125767 , P0127623 , P0127849 , P0128225 , P0128420 , P0128875 , P0129052 , P0129155 , P0129451 , P0129572 , P0130354 , P0132046 , P0132726 , P0133301 , P0133777 , P0133835 , P0133836 , P0133837 , P0134515 , P0135473 , P0138875 , P0149304 , P0149305 , P0160131 , P0163554 , P0164049 , P0164216 , P0164438 , P0164532 , P0165078 , P0165079 , P0165080 , P0165081 , P0166465 , P0166466 , P0166834 , P0167425 , P0167651 , P0167682 , P0169577 , P0170398 , P0170970    , P0172128 , P0172129 , P0172423 , P0172424 , P0172425 , P0172426 , P0172623 , P0172718 , P0175806 , P0175807 , P0177061 , P0178143 , P0181261 , P0183905 , P0186868 , P0186870 , P0188652 , P018869 , P0189663 , P0189664 , P019147 , P019148 , P019149 , P019150 , P019151 , P019275 , P019276 , P019277 , P019283 , P019322 , P019323 , P019326 , P019327 , P019801 , P019802 , P019803 , P019804 , P020452 , P020453 , P021332 , P021333 , P021792 , P021794 , P022018 , P022019 , P023898 , P023901 , P024623 , P025150 , P025151 , P026436 , P026437 , P026438 , P026439 , P026440 , P026619 , P026620 , P026621 , P026804 , P027081 , P027082 , P027321 , P027322 , P027323 , P027744 , P027953 , P028299 , P030415 , P030416 , P030863 , P030864 , P031143 , P031144 , P031530 , P034344 , P034345 , P034346 , P034424 , P034425 , P034542 , P034611 , P035841 , P035976 , P035977 , P036591 , P039475 , P039476 , P039591 , P039749 , P041222 , P041223 , P041615 , P041616 , P041932 , P041972 , P041973 , P041974 , P042167 , P042282 , P042284 , P042285 , P048169 , P048170 , P050022 , P050433 , P051327     , P051626 , P053704 , P054140 , P054376 , P054593 , P056636 , P056860 , P058001 , P058621 , P058622 , P059546     , P059634     , P059635     , P060675 , P060676 , P062509 , P062978 , P064317 , P065625 , P065806 , P066048 , P067245 , P067504 , P068235 , P068236 , P069079 , P069178 , P069334 , P069335 , P069615 , P070949 , P071725 , P073528 , P075036 , P075802 , P075946 , P076331 , P076526 , P079075 , P079321 , P081497 , P081583 , P081584 , P081854 , P082674 , P083243 , P083666 , P084374 , P086826 , P087950 , P088488 , P094207 , P094411 , P096286 , P097604 , P0M6050 , PO137838 , PO146396 , PO190805 , PO19275 , PO47568 , R61213 Class II There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. Arjo Hospital Equipment AB
Devices ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. 2359 , P032387 , P034422 , P034423 , P034732 , P035210 , P035600 , P035705 , P036000 , P037150 , P038617 , P038752 , P038753 , P038894 , P039590 , P040635 , P040812 , P041044 , P041473 , P041617 , P042386 , P042430 , P042473 , P042474 , P042595 , P042596 , P042657 , P042727 , P042728 , P042842 , P043140 , P043232 , P043521 , P045035 , P045367 , P046255 , P046256 , P047337 , P047480 , P049467 , P049468 , P050432 , P050489 , P052233 , P056073 , P056861 , P056862 , P058743 , P060073 , P060179 , P060529 , P060857 , P060858 , P060918 , P060919 , P060920 , P062505 , P062609 , P062847 , P063301 , P063853 , P064395 , P064483 , P064500 , P064575     , P064719     , P064815 , P064816 , P065140 , P065141 , P065193 , P065314 , P065400 , P065401 , P066218 , P066570 , P066615 , P067019 , P067086 , P067087 , P067393 , P067441 , P067482 , P068002 , P068266 , P068700 , P068988 , P070081 , P070435 , P070443 , P070713 , P070770 , P071349 , P071350 , P071451 , P073778 , P073847 , P073934 , P075170 , P076716 , P076719 , P076849 , P076950 , P078419 , P079322 , P079323 , P080384 , P083938 , P084481 , P084594 , P085062 , P086507 , P086508 , P086830 , P086831 , P087584     , P087585 , P087853 , P088197 , P088210 , P088272 , P088570 , P088655 , P092355 , P093705 , P093834 , P094960 , P094961 , P096673 , P096674 , P096675 , P097132 , P097311 , P097500 , P099166 , P099167 , P099444 , P099445 , P099721 , P100052 , P100053 , PO106703 , PO106704 , PO106706 , PO29057 , PO29058 , PO29059 , PO84691 , PO84692 , PO84693 , PO84694 , PO84695 , PO84696 , PO84697 , PO84698 ; 1) Model Number C1080; Serial Numbers (US): 416930 , 766425 , 473239 , 773201 , 851902 , 416917 , 491904 , 545574 , 473246 , 416932 , 473245 , 473238 , 82730 , 783942 , 416919 , 473243 , 545569 , 473234 , 416920 , 416926 , 473236 , 830902 , 416927 , 491906 , 416931 , 416921 , 491895 , 745779 , 561704 , 561689 , 766423 , 416922 , 774737 , 416925 , 416928 , 491908 , 473242 , 491900 , 822726 , 836910 , 545567 , 473233 , 561700 , 491903 , 836902 , 82996 , 473240 , 745778 , 747442 , 561691 , 561695 , 561701 , 491893 , 545579 , 725635 , 304528 , 304527 , 747444 , 745780 , 473241 , 545573 , 816751 , 816748 , 812748 , 836904 , 304530 , 491896 , 545580 , 545570 , 545568 , 561693 , 774730 , 473232 , 491901 , 725633 , 561699; Serial Numbers (Foreign): 18045 , 18151 , 18152 , 18153 , 18154 , 18155 , 18366 , 93080 , 114143 , 276987 , 366998 , 378830 , 378831 , 386998 , 398332 , 398333 , 442500 , 442501 , 442502 , 475308 , 479362 , 479363 , 479364 , 479365 , 479367 , 493548 , 493549 , 493550 , 493551 , 493552 , 493553 , 493554 , 493555 , 493556 , 493557 , 511571 , 511572 , 511573 , 566464 , 566465 , 602665 , 684642 , 695358 , 701859 , 701948 , 725623 , 725624 , 725625 , 725626 , 725627 , 725629 , 725631 , 745783 , 751632 , 765776 , 765777 , 778573 , 778575 , 778576 , 778577 , 778578 , 822721 , 822721 , 822730 , 822730 , 822731 , 822732 , 830904 , 830905 , 831024 , 831025 , 840921 , 844771 , 848196 , 848199 , 848203 , 848206 , 848207 , 848931 , 857830 , 857831 , 871844 , 873308 , 873309 , 873310 , 873311 , 895437 , 895438 , 901247 , 901248 , 904455 , 905470 , 925888 , 925889 , 925890 , 925901 , 929765 , 929766 , 929769 , 934938 , 934939 , 935002 , 945140 , 945142 , 945143 , 945145 , 945146 , 945147 , C1080 , CO10800103 , CO10800104 , CO10800105 , CO10800106 , CO10800107 , D778574 , G/493557 , P0032040 , P0032041 , P0100336 , P0100409 , P0101003 , P0101329 , P0101330 , P0101331 , P0101332 , P0101333 , P0101510 , P0101511 , P0101512 , P0101513 , P0101514 , P0101515 , P01 Class II There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. Arjo Hospital Equipment AB
Devices ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required. 1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 , 475309 , 530882 , 554079 , 554082 , 566463 , 584837 , 586554 , 592203 , 592204 , 592205 , 592206 , 597027 , 597028 , 605859 , 646152 , 664632 , 680670 , 680699 , 693924 , 695671 , 699563 , 712231 , 714227 , 714228 , 714229 , 716809 , 720277 , 725622 , 731631 , 745781 , 745782 , 747354 , 747355 , 748161 , 748162 , 748635 , 761635 , 766430 , 766430 , 766431 , 766431 , 771194 , 771195 , 771197 , 771198 , 798571 , 816742 , 821563 , 821564 , 821704 , 821705 , 821706 , 821707 , 822714 , 823713 , 823713 , 823714 , 832524 , 832525 , 832526 , 832527 , 832528 , 840918 , 840919 , 840919 , 840920 , 840920 , 840922 , 840923 , 840924 , 840925 , 840947 , 840948 , 840949 , 840950 , 847439 , 853387 , 855259 , 855260 , 855261 , 855262 , 871837 , 871840 , 871841 , 871842 , 871843 , 872720 , 873306 , 873307 , 873307 , 881203 , 881204 , 881205 , 881206 , 881207 , 889938 , 889939 , 901232 , 901233 , 901234 , 901236 , 901237 , 901244 , 904448 , 904449 , 904449. , 913969 , 916105 , 916108 , 924589 , 925887 , 929764 , 929772 , 945149 , 945151 , 945154 , 945160 , 8401918 , 648568Z1894 , 648569Z1894 , C1000 , M/M-1 , M/M-10 , M/M-2 , M/M-3 , M/M-4 , M/M-5 , M/M-6 , M/M-7 , M/M-8 , M/M-9 , P0100097 , P0100172 , P0100337 , P0100523 , P0100655 , P0100723 , P0101916 , P0101927 , P0101928 , P0101929 , P0101930 , P0101931 , P0102404 , P0102894 , P0102895 , P0102896 , P0102897 , P0102898 , P0103581 , P0103582 , P0103583 , P0106046 , P0106705 , P0106707 , P0108275 , P0108276 , P0109784 , P0110620 , P0111754 , P0114163 , P0114164 , P0115132 , P0118357 , P0118358 , P0120283 , P0120855 , P0120862 , P0121025 , P0121307 , P0121308 , P0121605 , P0121857 , P0122187 , P0122459 , P0125170 , P0126006 , P0126089 , P0126317 , P0126318 , P0126326 , P0126865 , P0126866 , P0126867 , P0128593 , P0128594 , P0130033 , P0132561 , P0133271 , P0133392 , P0133482 , P013391 , P0134514 , P0137082    , P0137164 , P0137540 , P0138061 , P0138062 , P0138242 , P0138520 , P0138710 , P0138780 , P0138781 , P0139072 , P0143580    , P0143581    , P0143714 , P0144844    , P0144845    , P0145951 , P0146630 , P0146631 , P0146632 , P0147602 , P0147657 , P0147790 , P0147791 , P0147792 , P0148713 , P015878 , P015879 , P015880 , P015881 , P015882 , P015883 , P015884 , P015885 , P015886 , P015887 , P015888 , P015889 , P015890 , P015891 , P015892 , P015893 , P015894 , P015895 , P015896 , P015897 , P016101 , P016102 , P0162202 , P0162203 , P0162204 , P0162368 , P0162369 , P0163463 , P016386 , P016387 , P016388 , P016389 , P016392 , P016394 , P0164651    , P0164652    , P0164972 , P0167357 , P0167465 , P0167466 , P0168015 , P0170588 , P0170689 , P0170690 , P0170968    , P0170969    , P0170981 , P0170982 , P0171406 , P0171918 , P0175182 , P0175368 , P0175369 , P0175370 , P0175545 , P0175546 , P0176591 , P0177062 , P0177063 , P017742 , P0178144 , P0178145 , P0178146 , P0178147 , P0178884 , P0178994 , P0179154 , P0180855 , P0180856 , P0180857 , P0180858 , P0181259 , P0181260 , P0182476    , P0183725 , P0183726 , P0183727 , P0183728 , P0183729 , P0183730 , P0183731 , P0183732 , P0184221 , P0184222 , P0185060 , P0185078 , P0185233 , P0185307 , P0185896 , P0189314 , P0189315 , P0189316 , P019458 , P019459 , P019460 , P019461 , P021789 , P021791 , P021888 , P021894 , P022021 , P022022 , P022023 , P022759 , P022760 , P022761 , P023170 , P025354 , P025355 , P025968 , P025969 , P026033 , P026034 , P026125 , P026126 , P026302 , P026303 , P027324 , P027461 , P027954 , P027956 , P029384 , P031686 , P031774 , P03 Class II There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40. Arjo Hospital Equipment AB
Food saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105 Lot #s 81721,81722,101022,61327,61328,61329,31424,31422,31423,40926,40925,33125,31421,31324,30922,30923,30924,31322,31323,31321,12428,30925, 12426,21325,12521,112214,112216,52231,52232,20634,31832,31833,40833,31831,31838,33033,330353,33031,33034,33032,31834,31837,31835,31836, 20634,20635,21837,21834,21835,21836,31537,11131,20633,121024,121025,121026,121027,21831,36000250,110524,110525,101024,33126,61325, 981723,101023,110523 Class II Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013. AMS Health Sciences
Food Mini Butter Croissant 6 Pack Ingredients: Wheat Flour (unbleached enriched wheat flour, malted barley flour, niacin, Iron, thiamin mononitrate, riboflavin, ascorbic acid, folic acid), Butter, Water, Sugar, Non Fat Dry Milk, Yeast, Salt, Dough Conditioner (dextrose, wheat flour, soybean oil, ascorbic acid, natural enzymes). CONTAINS: MILK, WHEAT, SOY. NET WT 9.0 oz (0.56 lb) COUNT/PACKAGES 1 SELL-BY DATE 04/22/2014 TOTAL PRICE $4.99 Dist. by Whole Foods Market 8190 Park Lane, Dallas, TX 75231 UPC 2 28719 00499 1 and PLU #8719 Class I Undeclared egg allergen Whole Foods Market Brand 365, Llc
Food Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a plastic wrapped package. MFD: 10.17.2013, EXP: 07.18.2014 Class I The product was found to contain undeclared eggs plus unapproved colors Ponceau 4R (E124, Acid Red 18) and Acid Yellow 73 (uranine) based on sampling and analysis by New York State Department of Agriculture & Markets. Domega NY International Co Ltd
Biologics Citra Labs ACD-A, Anticoagulant Citrate Dextrose Solution, Solution A, USP, 50 mL. Intended for use as an anticoagulant in the extracorporeal blood processing. PN 60S3 Batch Code/Exp Date: F23 2015/05; G22 2015/06; H15 2014/07; H16 2014/07; J14 2014/08; J15 2014/08; K110 2014/09; K17 2014/09; L13 2014/10; L17 2014/10 Class III ACD-A (Anticoagulant Citrate Dextrose Solution, Solution A, USP 50mL) contaminated with silicone particles, was distributed. Citra Labs LLC.
Devices The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton. Product Code: 4986.09; Lot: 51000232 Class II Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232. Richard Wolf Medical Instruments Corp.
Drugs Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77. Lot 3023805 Exp. 11/15 Class II Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol Mylan Pharmaceuticals Inc.
Drugs N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Lot #: 86513, Exp 07/23/2014 Class I Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. Unique Pharmaceutical, Ltd
Drugs All sterile products within expiry All Lots Class II Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile. Unique Pharmaceutical, Ltd
Food PEONY MARK brand ROASTED AND SALTED PUMPKIN SEED, NET WT. 12 oz. (340 gm), Barcode 6 932692 225765, PRODUCT OF CHINA --- PACKED FOR: STARWAY INC 137 GRATTAN STREET, BROOKLYN, NEW YORK 11237 --- NUTRITION FACTS: Serving Size 1 oz., Servings per container 12 Barcode 6 932692 225765 and no other coding Class I The product contained undeclared sulfites (873.3 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets. Starway Inc.
Drugs ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01 MP2292 Exp. 01/16 Class II Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance. Zydus Pharmaceuticals USA Inc
Biologics Red Blood Cells Leukocytes Reduced W036212456713; W036212430018; W036211169353; W036211165203 Class II Blood products, collected from donors who lived in a malarial endemic area, were distributed. Belle Bonfils Memorial Blood Center
Devices Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure. Barcode: 10603295240532 CATALOG NO. : 962004000 Lot # OSA-149328 Lot # OSA-181610 Lot # OSA-161157 Class II The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. DePuy Orthopaedics, Inc.
Devices BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Batch/Lot No. 4767162 (exp. date 30-JUN-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Batch/Lot No. 4752351 (exp. 31-Jan-16) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 4F-55 cm, UPN Product No. H965750121, REF/Catalog No. 75-012, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Batch/Lot No. 4748676 (exp. 31-Jan-16) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M2309831, REF/Catalog No. 60M230983, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. Batch/Lot No. 4756773 (exp. 31-May-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 Batch/Lot No. 4763165 (exp. 31-May-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801 Batch/Lot No. 4748898 (exp. 31-May-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M1318471, REF/Catalog No. 60M131847, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Batch/Lot No. 4754060 (exp. 31-May-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0501981, REF/Catalog No. 60M050198, STERILE --- Intended for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. Batch/Lot No. 4754052 (exp. 30-Apr-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo Hybrid PICC, 6F-55 cm TRIPLE LUMEN, UPN Product No. H96560M0367061, REF/Catalog No. 60M036706, STERILE --- Indicated short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. Batch/Lot No. 4753216 (exp.30-Apr-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO Technology, 5F-55 cm DUAL LUMEN, UPN Product No. H96560M0367051, REF/Catalog No. 60M036705, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. Batch/Lot No. 4753215 (exp. 30-Apr-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M0224751, REF/Catalog No. 60M022475, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media. Batch/Lot No. 4753765 (exp. 31-May-15) Class II NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes. Navilyst Medical, Inc
Devices Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010. Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Class II Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of potential elevated temperatures in the seat and back lumbar areas of the chair. Nemschoff Chairs, Inc.
Devices RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586, NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023, 578910, 578913, R578910, R578912, R578913, 582631, and 592125. Class II Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient. DePuy Orthopaedics, Inc.
Biologics Bone 0087050120; 0087050122; 0087050124; 0087050125; 0087050126; 0087050127; 0087050128; 0087050129; 0087050131; 0087050132; 0087050133; 0087050134; 0087050135; 0087050136; 0087050137; 0087050138; 0087050140; 0087050141; 0087050142; 0087050144; 0087050145; 0087050146; 0087050147; 0087050148; 0087050149; 0087050150; 0087050151; 0087050152; 0087050153; 0087050154; 0087050155; 0087050156; 0087050157; 0087050158; 0087050161; 0087050162; 0087050163; 0087050164; 0087050166; 0087050167; Class III HCTP allografts, mislabeled with an extended expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Devices RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Item 66800058 Lot # M400021 & Item 66800913 Lot # M400067 Class II RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Smith & Nephew, Inc.
Devices RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124 Class II RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Smith & Nephew, Inc.
Devices RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Item 66800912 Lot # M400071 Class II RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. Smith & Nephew, Inc.
Devices Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista® System. lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01. Class II Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control limits, this drift may not have been detected. Due to the drift, Siemens is revising the expiration date of this product. Siemens Healthcare Diagnostics, Inc.
Biologics Bone 0086540140; 0086540141; 0086540142; 0086540143; 0086540144; 0086540145; 0086540146; 0086540147; 0086540148; 0086540150; 0086540151; 0086540152; 0086540149; Class III HCTP allografts, mislabeled with an extended expiration date, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Veterinary Naphazoline HCI - 0.025% per 14.78 mL bottle.Oval 15-mL eye drop container labeled and placed inside of brand name box. Lot # 083012 Exp. Date 8/14 Class II The products includes an active ingredient that has been linked to accidental ingestion that has caused serious harm to children. Vetix Inc.
Veterinary Pheniramine Maleate 0.3% per 14.78 mL bottle.Oval 15-mL eye drop container labeled and placed inside of brand name box. Lot # 112612 Exp. Date 11/15 Class II The products includes an active ingredient that has been linked to accidental ingestion that has caused serious harm to children. Vetix Inc.
Veterinary ermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 35) 6274-H12, AirLife Isothermal Infant Respiratory Breathing Circuit, 7 ft., Heated, X1 Per Bag, 20 Per Case, CareFusion; 36) 6301-H12, AirLife Isothermal Infant Respiratory Breathing Circuit, 7 ft., Heated, X1 Per Bag, 20 Per Case, CareFusion; 37) 6313-501, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 38) 6459-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 39) 6485-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 40) 6588-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 41) WYE KIT INFANT 30/CS, Product Code 6603-504 ; 42) 6862-504, AirLife, Isothermal Breathing Circuit 2.1 m (7'), Infant Inspiratory Line Heated, CareFusion; 43) 6921-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 44) 6942-4H2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 45) 7100-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 46) 7147-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 47) 7156-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 48) 7184-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 49) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7206-4S2 ; 50) 7213- 4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 51) 7354-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 52) 7395-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 53) 7407- 4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 54) 7431-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 3 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 55) 7441-4S2, AirLife, Isothermal Breathing Circuit 1.5 m (5'), Infant Respiratory Circuit Heated, CareFusion; 56) 7483-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 57) 7526-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 58) 7575-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 59) 7582-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 60) 7588- 4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 61) 775687-101, AirLife, Infant Circuit NCPAP, MR730, For further Processing by SensorMedics, X30 Per Case, CareFusion; 62) 775687-102, AirLife Infant Circuit NCPAP, MR850, For Further Processing by SensorMedics, X30 Per Case, CareFusion; 63) 9052 -4S2, AirLife, Isothermal Breathing Circuit 1.3 m (4.5'), Infant Respiratory Circuit Heated, CareFusion; 64) 9053-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 65) 9054-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 66) 9055-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 5 ft., Heated, X1 Per Bag, 30 Per Case, CareFusion; 67) 9056-4S2, AirLife Isothermal Infant Respiratory Breathing Circuit, 4 ft., Heated, X1 Per Bag, All lots of the following products: 1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product  ...
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Class II The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient. Carefusion 2200 Inc
Veterinary Suprelorin F (DESLORELIN ACETATE) 4.7 mg Implant. NOT APPROVED BY FDA - Legally marketed as an FDA Indexed Product under MIF 900-013. FOR USE IN FERRETS ONLY. Extra-label use is prohibited. This product is not to be used in animals intended for use as food for humans or other animals. Lot Numbers SCV281B21 and SCV281B51 Class II The recalled product was subject to severe temperature excursions during product transit from Australia to the United States. Virbac AH, Inc
Veterinary Metacam (meloxicam) Oral Suspension 0.5 mg/mL packaged in 15 ml plastic bottles, RX, NADA 141-213, UPC 012313601416, Manufactured for Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO. Lot: AH001AN, Expiry: 31 Mar 2015; and Lot: AH006JG, Expiry 31 Oct 2015 Class II The product strength printed on the bottle label is different from the product strength listed on the display carton (outer packaging). Boehringer Ingelheim Vetmedica Inc
Veterinary Metacam (meloxicam) Oral Suspension 1.5 mg/mL packaged in 10 ml plastic bottles, RX, NADA 141-213, UPC 012313601515, Manufactured for Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO. Lot: 5402LHT, Expiry: 30 Nov 2014; Lot: AH001AR, Expiry: 30 Jun 2015; and Lot: AH001G4, Expiry 31 Jul 2015 Class II The product strength printed on the bottle is different from the product strength listed on the display carton (outer packaging). Boehringer Ingelheim Vetmedica Inc
Food Frozen jalapeno bagels sold under the Maple Leaf Bakery brand in three different sizes: 3 oz. (64 bagels/case), 4 oz. (78 bagels/case), and 4.5 oz. (72 bagels/case) Product Code (SKU): 39677 03041 3; Best Before Dates: *** 3oz. bagels- Best Before 2015 APR 12 *** 4oz. bagels Best Before 2014 AUG 07, 2014 AUG 08, 2014 AUG 14, 2015  ...
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Class II Wholesome Harvest Baking, Inc. ("WHB"), formerly Maple Leaf Bakery, Inc., of Chicago is initiating a voluntary recall of frozen in-store bakery Jalapeno Bagel based on reports of foreign material (glass pieces and stones) in product. Wholesome Harvest Baking, Inc.
Food Twix Unwrapped Bites 7.0 oz. distributed by Mars chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 040000484325 contained in a Metallized-golden stand up pouch (SUP) package 5 pouches per carton, 2 cartons per case Lot # 421BA4GA60 Class I Mars Chocolate North is recalling Twix Brand Unwrapped Bites 7 oz. pouch due to undeclared peanuts and eggs. Mars Chocolate North America
Devices Philips Healthcare Integris Allura 15 -12 Model Number: Integris Allura 15-12 Serial Number: 16741023 Class II Philips had discovered through a field service testing where a device failed to comply with a Federal standard. Philips Medical Systems, Inc.
Food Publix brand Jalapeno Bagels, sold in self service bins and counter sales. Item # 76669, Lot # 002-76669-00000; serve service bins Item # 964707, Lot # 000-00000-00000; over the counter Class II May contain pieces of glass and small stones. Publix Super Markets, Inc.
Food Wheat Cake (Maruto "C" Cake), 6.3 ounces (180g), individually packaged in gold foil pouches and sold under the Maruto Brand. Sold at retail locations in display cases containing 8 bars per display case. Lot Code: 55-H422 Class II This voluntary recall has been initiated because Maruto 'C' Cakes (Wheat Cakes) omitted soy lecithin as an ingredient and an accompanying allergen warning. Ikko International Trading LLC
Devices GE Healthcare Carescape Patient Data Module Mfg Lot or Serial # SA307020379GR SA307020383GR SA307020386GR SA307020391GR SA307020393GA SA307020396GA SA307020397GA SA307020399GR SA307020400GA SA307030405GR SA307030411GR SA307030412GR SA307030413GR SA307030417GA SA307030419GA SA307030420GA SA307030423GA SA307050429GA SA307070436GR SA307070438GR SA307070441GR SA307070442GR SA307070446GA SA307070447GR SA307070448GA SA307070449GR SA307070450GR SA307070453GR SA307070454GR SA307070455GR SA307080459GA SA307080462GR SA307080463GR SA307080466GA SA307080467GA SA307080469GA SA307080472GA SA307080473GR SA307080477GR SA307080478GR SA307080484GA SA307080488GA SA307080489GA SA307080491GA SA307080493GR  ...
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Class II GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly. GE Healthcare, LLC
Food Hostess Frosted Bagged Donettes, 11.25 oz UPC: 8 88109 15002 0 Best By Dates (2014): AUG 29, 30, 31 SEPT 01, 05, 06, 08, 09, 10, 18, 19, 20, 21, 24, 25, 26, 27 OCT 01, 02, 03 Julian Date- Lot Codes: 181, 182, 183, 184, 188, 189, 191, 192, 193, 196, 197, 198, 199, 202, 203, 204, 205, 209, 210,  ...
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Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Hostess Powdered Bagged Donettes, 10.5 oz. UPC: 8 88109 15004 4 Best By Dates (2014): SEPT 24 OCT 02, 03, 04 Julian Date- Lot Codes: 202, 210, 211, 212 Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Hostess Powdered Single-Serve Donettes, 3 oz., 6 ct. UPC: 8 88109 05004 7 Best By Dates (2014): AUG 29, 30, 31 SEPT 05, 06, 07, 08, 09, 17, 18, 19, 20, 21, 24, 25 OCT 01, 02, 03, 10 Julian Date- Lot Codes: 181, 182, 183, 188, 189, 190, 191, 192, 195, 196, 197, 198, 199, 202, 203, 209, 210, 211, 219 Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Hostess Frosted Bagged Donettes- FROZEN ONLY, 11.25 oz. UPC: 8 88109 15002 0 Best By Dates (2014): AUG 29, 30, 31 SEPT 01, 05, 06, 08, 09, 10, 18, 19, 20, 21, 24, 25, 26, 27 OCT 01, 02, 03 Julian Date- Lot Codes: 181, 182, 183, 184, 188, 189, 191, 192, 193, 196, 197, 198, 199, 202, 203, 204, 205, 209, 210,  ...
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Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Hostess Powdered Bagged Donettes- FROZEN ONLY, 10.5 oz. UPC: 8 88109 15004 4 Best By Dates (2014): SEPT 24 OCT 02, 03, 04 Julian Date- Lot Codes: 202, 210, 211, 212 Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Hostess Powdered Single-Serve Donettes- FROZEN ONLY, 3 oz., 6 ct. UPC: 8 88109 05004 7 Best By Dates (2014): AUG 29, 30, 31 SEPT 05, 06, 07, 08, 09, 17, 18, 19, 20, 21, 24, 25 OCT 01, 02, 03, 10 Julian Date- Lot Codes: 181, 182, 183, 188, 189, 190, 191, 192, 195, 196, 197, 198, 199, 202, 203, 209, 210, 211, 219 Class II Products recalled due to potential for mold growth. Laboratory analysis for products manufactured demonstrated a higher-than-average moisture content. Hostess Brands LLC
Food Roma Tomatoes, 25lbs. case Lot Code: 23914 214 Class I Expo Fresh is recalling Roma Tomatoes because they have a potential to be contaminated with Salmonella. Expo Fresh L.L.C
Drugs Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01 Lot 66482CW, Exp 04/16 Class II Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing. Astellas Pharma US Inc
Devices Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek® and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE Model/Product Number: B30-102 Lot #416130 Exp. 12/2016 Class II Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure. Biomedix, Inc.
Drugs METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01. Lot #: 283700, Expiry: 11/14; Lot #: 291400, Expiry: 01/15; and Lot #: 303500, Expiry: 04/15. Class II Defective Container: Product leaks when inverted. VistaPharm, Inc.
Food Frozen Pasteurized Human Milk in glass bottles. Label contains lot code followed by expiration date (month day year) and the description of the product which states Mature Milk. There is a Mothers' Milk Bank logo MMBMT-050114-71-1 through MMBMT-050114-71-12. 050114 represents the date the milk was pasteurized; 71 refers to the batch number; 1 refers to the bottle number. A total of 46 bottles were pasteurized for batch 71. Class III Donor answered NO to question #32 "In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?" It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery. Mothers' Milk Bank of Montana
Food Frozen Unpasteurized Human Milk in glass bottle. No labeling provided No lot coding Class III Donor answered NO to question #32 "In the last 28 days, have you ever had a vaccine for measles, mumps or rubella?" It was later discovered that she had in fact received live vaccines for influenza, DTAP and MMR after delivery. Mothers' Milk Bank of Montana
Devices Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: 426-796 Lot Number: 298987 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: 534801 Lot Number: 296986 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: LC-0060 Lot Number: 300445 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: 59601 Lot Number: 300233 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: 51401 Lot Number: 300649 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: 53151 Lot Number: 300143 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Devices Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue. Product Code: C4320-450B Lot Number: 300403 Class I The affected lots could have NBF concentrations that are lower or higher than the desired specifications. Richard-Allan Scientific Company
Food naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for cherry berry granola labeled in part as: Ingredients: Whole grain oats, brown sugar, dried cranberries (cranberries, sugar, sunflower oil) almonds, coconut, pecans, dried cherries (cherries, sugar, sunflower oil), maltodextrin [dietary fiber], natural flavor, salt, cinnamon, mixed tocopherols (vitamin E, soybean oil). Contains: Tree nuts (almonds, coconut, pecans). Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy. Distributed by NatureBox San Carlos, CA 94070 CORRECT berry macaroon granola UPC: 8 52523 00590 7 INCORRECT: Cherry berry granola UPC: 8 52523 00575 4 Lot Number: 3BC14204 Expiration Date: 3/10/15 Class II Firm discovered a pouch that had an incorrect back label. The front of the pouch was correctly labeled Cranberry Macaroon Granola but the back of the pouch was incorrectly labeled with the label for Cherry Berry Granola. NatureBox, Inc.
Devices Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290 Class II Investigation determined that units supplied were missing the 4x21 degree helix angle. Biomet, Inc.
Drugs Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 Lot 13JG2616 Exp. 07/16 Class II Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample. Janssen Ortho L.L.C.
Food Mars Chocolate North America Milk Chocolate M & M's Net Wt. 3.40 oz packed in a brown, 3 inch x 6.5 inch cardboard box 12 Theater boxes per case Distributed by Mars Snackfoods US LLC., Hackettstown, NJ 07840-1503 UPC 40000294764 417DH4JP09; 417EM4JP10; 417FM4JP09; 418AG4JP10; 418BG4JP10; 418CG4JP10; 418DM4JP09; 418EG4JP10; 419AM4JP09; 417EG4JP09; 417FG4JP09; 417FM4JP10; 418AM4JP09; 418BM4JP10 ;418CM4JP10; 418DM4JP10; 418EM4JP09; 419AM4JP10; 417EG4JP10; 417FG4JP10; 418AG4JP09; 418AM4JP10; 418CG4JP09; 418DG4JP10; 418EG4JP09; 418EM4JP10; and 419BM4JP10 Class II Mars Chocolate North America is recalling M & Ms due to undeclared peanuts. Mars Chocolate North America
Devices Biosense Webster's Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577 Class II Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is connected with the CARTO®3 System, Error 6103 for expiration is displayed on the CARTO®3 System and the catheter cannot be used. STERILMED, INC.
Drugs Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09. Lot #140502, Exp 10/31/2015 Class II Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers. Mckesson
Devices Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. Catalog Number: 110010849 Lot Number: 169620, 253190 Class II An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Biomet, Inc.
Devices Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. Catalog Number: 110010850 Lot Number: 231120, 253210 Class II An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Biomet, Inc.
Devices Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. Catalog Number: 110010851 Lot Number: 139800, 139810, 139820 Class II An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use. Biomet, Inc.
Devices McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1. Class II Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations. Mckesson Information Solutions LLC
Drugs E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured in USA for E-Z EM, Inc. Lake Success, NY 11042 by Tower Laboratories LTD Centerbrook, CT 06409 NDC 10361-793-01 Lot # F12C01; Exp. 02/15 Class III Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months. Bracco Diagnostic Inc
Devices StarMedTec LightTrail® Reusable Fibers, 365 um; Material/Part Number: 6453 Material/Part Number: 6453 Batch Code: 2011-00238 Class II Product is not cleared for use with lasers other than the Auriga XL system Boston Scientific Corporation
Devices StarMedTec LightTrail® Reusable Fibers, 600 um; Material/Part Number: 6455 Material/Part Number: 6455 Batch Code: 2012-00268, 2013-00443 Class II Product is not cleared for use with lasers other than the Auriga XL system Boston Scientific Corporation
Devices StarMedTec LightTrail® Reusable Fibers, 800 um; Material/Part Number: 6457 Material/Part Number: 6457 Batch Code: 2011-00217, 2012-00239, 2012-00249, 2012-00258 Class II Product is not cleared for use with lasers other than the Auriga XL system Boston Scientific Corporation
Devices ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Lot Numbers: 1614, 1814, 1914 Class II Product sterility is not assured Bio-Detek, Inc.
Devices ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Lot Numbers: 1614, 1814 Class II Product sterility is not assured Bio-Detek, Inc.
Devices ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Lot Numbers: 1614, 1914, 2114 Class II Product sterility is not assured Bio-Detek, Inc.
Devices ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. Lot Numbers: 1614, 1914, 2114 Class II Product sterility is not assured Bio-Detek, Inc.
Drugs Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablets, 30 count bottles, Rx only, Manufactured for Gilead Sciences, Inc. Foster City, CA 94404, NDC 61958-0701-1 TRUVADA (NDA 21-752; NDC 61958-0701-1) Lot# 002808, Expiration Date: 31 December 2017 Class III Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates. Gilead Sciences, Inc.
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