The Recall Desk

Archive

August 2012 recalls

875 recalls were announced in August 2012.

What the numbers show

Critical
155
Severe
348
High
251
Moderate
101
Low
20

Of the 875 recalls this month scored against our rubric, 18% are Critical, 40% are Severe.

Which agencies issued them

301–400 of 875

  • SevereFDA (Drugs)·D-1629-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZ
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1481-2012·2012-08-22

    Franck's Lab Recalls Cefazolin Sterile Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile Cefazolin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1476-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.

    Product
    BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1565-2012·2012-08-22

    Franck's Lab Recalls Sterile Lithium Chloride Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile lithium chloride injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the clean room.

    Product
    LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1622-2012·2012-08-22

    Franck's Lab Recalls Sterile Tetracaine Ophthalmic Solutions Due to Contamination

    Franck's Lab Inc. is recalling sterile tetracaine ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1517-2012·2012-08-22

    Franck's Lab Recalls Etomidate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Etomidate 0.2% Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2012·2012-08-22

    Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1577-2012·2012-08-22

    Franck's Lab Recalls Sterile Metoclopramide Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile metoclopramide HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2012·2012-08-22

    Recall of Sterile Ketorolac Tromethamine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ketorolac tromethamine injectable products because environmental sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODU
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1617-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1494-2012·2012-08-22

    Franck's Lab Recalls Cyclosporine Ophthalmic Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling 40 units of cyclosporine ophthalmic drugs because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1614-2012·2012-08-22

    Franck's Lab Recalls Sterile Rubidium Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.

    Product
    RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Amphotericin B Drugs Due to Contamination

    Franck's Compounding Lab is recalling sterile Amphotericin B drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML N
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1609-2012·2012-08-22

    Franck's Lab Recalls Pyridoxine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Pyridoxine 100mg/mL Injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1631-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFER
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1524-2012·2012-08-22

    Franck's Lab Recalls Forskolin/Phentolamine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Forskolin/Phentolamine injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1510-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1632-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile glutathione products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1598-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1484-2012·2012-08-22

    Franck's Lab Recalls Sterile Chromium Picolinate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile chromium picolinate injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.

    Product
    BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1555-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination

    Franck's Compounding Lab is recalling sterile leucovorin vials because FDA environmental sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1572-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Hydromorphone Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal drug mixtures due to microorganisms and fungal growth found in the clean room.

    Product
    BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2012·2012-08-22

    Franck's Lab Recalls Copper Gluconate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Copper Gluconate 2mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1637-2012·2012-08-22

    Franck's Lab Recalls Sterile Vanadyl Sulfate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile Vanadyl Sulfate Solution injectable because FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine/Sufentanil Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile bupivacaine/sufentanil injections because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2012·2012-08-22

    Franck's Lab Recalls Zinc Chloride Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Zinc Chloride 10mg/ml Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1599-2012·2012-08-22

    Franck's Lab Recalls Sterile Phenylephrine Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile phenylephrine injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFER
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1506-2012·2012-08-22

    Franck's Lab Recalls Sterile DMSO and Heparin Solutions Due to Contamination

    Franck's Lab Inc. is recalling specific sterile DMSO and Heparin solutions because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1635-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1533-2012·2012-08-22

    Recall of Sterile Hyaluronic Acid Sodium Salt Injectable Drugs

    Franck's Lab Inc. is recalling sterile hyaluronic acid sodium salt injectable drugs due to the presence of microorganisms and fungal growth in the clean room.

    Product
    HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1643-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Water Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable water products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1639-2012·2012-08-22

    Franck's Lab Recalls Sterile Vancomycin and Dexamethasone Kits Due to Contamination

    Franck's Lab Inc. is recalling sterile vancomycin and dexamethasone kits because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA testing found microorganisms in the production clean room.

    Product
    BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1586-2012·2012-08-22

    Franck's Lab Recalls Moxifloxacin Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Moxifloxacin injectable products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1558-2012·2012-08-22

    Franck's Lab Recalls Sterile Lidocaine Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile lidocaine products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML 150
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1474-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions

    Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.

    Product
    BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1492-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1621-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination

    Franck's Compounding Lab is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1578-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2012·2012-08-22

    Franck's Lab Recalls Sterile EDTA Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile EDTA drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2012·2012-08-22

    Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns

    Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.

    Product
    BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1548-2012·2012-08-22

    Franck's Lab Recalls Iohexol Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 19 units of Iohexol injectable sterile drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1567-2012·2012-08-22

    Franck's Lab Recalls Sterile L-Tryptophan Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile L-Tryptophan injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1583-2012·2012-08-22

    Franck's Lab Recalls Sterile Mitomycin Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile Mitomycin/Lidocaine/Epinephrine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1942-2012·2012-08-22

    St Clair Foods Recalls Diced Yellow Onions for Listeria Risk

    St Clair Foods is recalling diced yellow onions distributed by Sysco in Tennessee due to potential Listeria monocytogenes contamination.

    Product
    4/5 SYS DICED YELLOW ONIONS, 720611 SUPC 7750243, Distributed by: SYSCO
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1519-2012·2012-08-22

    Franck's Lab Recalls Sterile Fluorescein/Indocyanine Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Fluorescein/Indocyanine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1537-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile hyaluronidase/methylprednisolone acetate injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2012·2012-08-22

    Franck's Lab Recalls Sterile Verapamil Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Verapamil HCL injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML INJECTABLE 20 MLS 40 ML 50 ML 50 MLS (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1511-2012·2012-08-22

    Recall of Sterile Ophthalmic Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile ophthalmic drugs due to microbial contamination found in the clean room.

    Product
    EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1596-2012·2012-08-22

    Recall of Penicillin G Potassium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Penicillin G Potassium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1564-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1514-2012·2012-08-22

    Franck's Lab Recalls Sterile Epinephrine Products Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile epinephrine products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS S
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2012·2012-08-22

    Recall of Procaine HCL Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Procaine HCL injectable products because FDA testing found microorganisms in the production clean room.

    Product
    PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJECTABLE 300 ML 360 ML 450 ML; PROCAINE HCL, P.F. 8% INJECTABLE 20 ML 60 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures

    Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1604-2012·2012-08-22

    Franck's Lab Recalls Povidone-Iodine Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific povidone-iodine ophthalmic solutions because FDA testing found microorganisms in the production clean room.

    Product
    POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V413000·2012-08-22

    Fisker Recalls 2012 Karma Vehicles Due to Cooling Fan Fire Risk

    Fisker is recalling 1,377 model year 2012 Karma vehicles because a manufacturing defect in the low temperature cooling fan may cause a direct short and vehicle fire.

    Product
    FISKER — FISKER KARMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1549-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the preparation clean room.

    Product
    IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2012·2012-08-22

    Franck's Lab Recalls Sterile Sodium Chloride Vials Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile sodium chloride injectable vials because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1618-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1561-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures

    Franck's Compounding Lab is recalling sterile ophthalmic drug mixtures due to the presence of microorganisms and fungal growth in the clean room where they were prepared.

    Product
    LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.0005%/0.25% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1557-2012·2012-08-22

    Franck's Lab Recalls Levothyroxine Sodium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Levothyroxine Sodium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1328-2012·2012-08-22

    FunFresh Foods Recalls Organic Cacao Nibs Due to E. coli Contamination

    FunFresh Foods Inc is recalling 500 units of World Berry Organic Cacao Nibs 6 oz due to E. coli contamination. The product was distributed to health and natural food stores in 30 states.

    Product
    FunFresh Foods World Berry Organic Cacao Nibs 6 oz, packaged in blue, brown, red, white, black and green packaging with red, black, yellow, white, and green print writing. The packaging is resealable.
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-2202-2012·2012-08-22

    Carestream DRX-1 System Battery Recall for Overheating Risk

    Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.

    Product
    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2188-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1937-2012·2012-08-22

    Icrest International Recalls Frozen Oyster Meat Due to Insanitary Conditions

    Icrest International LLC is recalling frozen oyster meat from Korea because it was prepared under insanitary conditions, potentially rendering it injurious to health.

    Product
    OYSTER MEAT IQF TINY 40/8OZ PRODUCT OF KOREA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2012·2012-08-22

    CareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls

    CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.

    Product
    Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2012·2012-08-22

    GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements

    GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.

    Product
    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2012·2012-08-22

    Zimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in instruments made of 455 stainless steel.

    Product
    00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures in units made of 455 stainless steel.

    Product
    Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, plac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1932-2012·2012-08-22

    Southern Home Pasta Salad Recalled for Potential Metal Fragments

    Southern Home is recalling specific lots of Pasta Salad Ranch with Bacon because they may contain metal fragments.

    Product
    Southern Home Pasta Salad Ranch with Bacon, 7.5 oz., UPC 0788002891, 12 packages per case
    Category
    Food
    Distribution
    4 states
  • HighCPSC·12253·2012-08-22

    Energizer Recalls Rotating Night Lights Due to Burn Hazard

    Energizer is recalling rotating night lights sold at Target because they can overheat and smoke, posing a burn hazard. No injuries have been reported.

    Product
    Energizer Rotating Night Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2012·2012-08-22

    Shiley Reusable Tracheostomy Tubes Recalled Due to Cannula Connection Issues

    Nellcor Puritan Bennett Inc. is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes due to consumer complaints regarding the connections and functions of the inner and outer cannula.

    Product
    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2192-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.

    Product
    00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2012·2012-08-22

    Maquet Pediatric Arterial Cannula Recall for Limited Flexibility

    Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.

    Product
    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during ex
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1943-2012·2012-08-22

    Baroody Imports Recalls Chiclets Chewing Gum for Unsafe Color Additives

    Baroody Imports Inc. is voluntarily recalling Chiclets Chewing Gum (Fruit Flavors) due to misbranded and unsafe color additives.

    Product
    Chiclets Chewing Gum Fruit Flavors; Made in Lebanon; Manufactured by Cadbury Adams Middle East S.A.L.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2214-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures.

    Product
    00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1935-2012·2012-08-22

    Icrest International Recalls Oyster Meat Due to Insanitary Conditions

    Icrest International LLC is recalling Oyster Meat IQF Large 5/4 Lbs due to preparation under insanitary conditions that may have contaminated the product.

    Product
    OYSTER MEAT IQF LARGE 5/4 LBS PRODUCT OF KOREA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2012·2012-08-22

    Roche Recalls COBAS AmpliPrep Sample Tube Input Barcode Clips

    Roche Molecular Systems is recalling certain lots of COBAS AmpliPrep barcode clips because they can cause sample tubes to stick, leading to aborted instrument runs.

    Product
    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2012·2012-08-22

    Nico BrainPath Sheath Recall Due to Incorrect Length Labeling

    Nico Corp. is recalling 15 BrainPath sheaths because 50mm units were mislabeled as 60mm, causing improper fit.

    Product
    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2184-2012·2012-08-22

    AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data

    AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.

    Product
    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
    Category
    Medical Device
    Distribution
    Distributed nationwide

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