The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
408
High
239
Moderate
175
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 44% are Severe.

Which agencies issued them

101–200 of 921

  • SevereFDA (Drugs)·D-1375-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services is recalling 1,527 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.

    Product
    1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1381-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

    Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.

    Product
    10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1389-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates

    PharMEDium Services is recalling 425 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1360-2016·2016-07-27

    Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

    Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

    Product
    0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1745-2016·2016-07-27

    Rucker's Sweet N Salty Sunflower Kernels Recalled for Listeria Contamination

    Rucker's Wholesale & Service Co. is recalling 1,032 bags of Sweet N Salty sunflower kernels due to Listeria monocytogenes contamination.

    Product
    SWEET N SALTY 10 OZ packaged in a clear plastic bag with sticky label under the UPC code 052545023396 and several brands including BIG R STORE'S, FAMILY CHOICE, FARM & HOME SUPPLY, JAYS SPORTING GOODS
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1760-2016·2016-07-27

    CRF Frozen Foods Recalls Organic Peas for Listeria Risk

    CRF Frozen Foods is recalling specific brands of frozen organic peas due to a potential for contamination with Listeria monocytogenes.

    Product
    Frozen Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 5 lb. The UPC is 8 46358 00063 3. Frozen IQF Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00069 5. Frozen Organic Premium Quality Sweet Peas, Organic by…
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1419-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates

    Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1367-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

    PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with glass particulate matter.

    Product
    0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1445-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination

    GlaxoSmithKline is recalling 18,000 tubes of Bactroban Ointment because of penicillin cross-contamination. The affected product is distributed nationwide and in Puerto Rico.

    Product
    Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1708-2016·2016-07-27

    Crescent Raw Pistachios Recalled for Potential Salmonella Contamination

    Crescent Specialty Foods is recalling 6 oz. bags of raw pistachios due to potential Salmonella contamination. The product was distributed in Oregon and Washington.

    Product
    Raw Pistachios, packaged in a 6 oz. clear, plastic bag, sold under Crescent brand. UPC 8 95296 00103 5. Product is labeled in part: Crescent *** PISTACHIO RAW Net Wt. 6 oz. (170g) *** Ingredients: Raw Pistachios *** Distributed by Crescent Specialty Foods, Inc. Everett, WA…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1379-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    Pharmedium Services, LLC is recalling 750 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution distributed nationwide due to the presence of glass particulate matter.

    Product
    10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1442-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination

    GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross contamination. The recall affects 28,131 tubes distributed nationwide and in Puerto Rico.

    Product
    Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1415-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 1,470 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.

    Product
    3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1398-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    Pharmedium Services, LLC is recalling 940 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1390-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 60 bags of compounded fentanyl and bupivacaine injectable solution nationwide because glass particulates were found in the active pharmaceutical ingredient.

    Product
    2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1759-2016·2016-07-27

    El Gordo Spices Recalls Ground Dried Shrimp for Undeclared Sulfites

    El Gordo Spices, LLC is recalling specific brands of ground dried shrimp because the labels failed to declare sulfites.

    Product
    Morelos Ground Dried Shrimp Net. Wt. 3 oz.; 1 oz.; El Gordo Ground Dried Shrimp Net. Wt. 3 oz.; La Azteca Ground Dried Shrimp Net. wt. 3 oz. all packaged in cellophane bags
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1374-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    Pharmedium Services, LLC is recalling 361 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1372-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate

    PharMEDium Services, LLC is recalling 866 bags of 0.5% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate.

    Product
    0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1397-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 250 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution because the active pharmaceutical ingredient was contaminated with glass particulate.

    Product
    2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1761-2016·2016-07-27

    CRF Frozen Foods Recalls Organic White Sweet Corn for Listeria Risk

    CRF Frozen Foods is recalling specific brands of frozen organic white sweet corn due to a potential for contamination with Listeria monocytogenes.

    Product
    Frozen Organic Super Sweet White Corn, Organic by Nature, net wt. 5 lb. The UPC is 8 46358 00064 0. Frozen Organic Super Sweet White Corn, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00070 1. Organic Super Sweet Yellow and White Cut Corn, Live Smart Schwan's…
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1392-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulate

    PharMEDium Services is recalling 950 bags of compounded fentanyl and bupivacaine infusions because glass particulate was found in the active pharmaceutical ingredient.

    Product
    2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1370-2016·2016-07-27

    Pharmedium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 10 bags of compounded sufentanil and bupivacaine solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1418-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 455 bags of compounded fentanyl and bupivacaine injectable solutions distributed nationwide. The recall is due to the presence of glass particulate matter in the active pharmaceutical ingredient.

    Product
    4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1427-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates

    PharMEDium Services is recalling 45 cassettes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16T010000·2016-07-27

    Vee Taiga M/T Tires Recalled for Sidewall Blistering and Separation

    Vee Tyre and Rubber Co. is recalling specific Taiga M/T tires due to sidewall blistering and interliner separation risks that could cause blowouts at high speeds.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1393-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services is recalling 1,476 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1361-2016·2016-07-27

    PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution due to the presence of glass particulate matter.

    Product
    0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1766-2016·2016-07-27

    Garden Fresh Foods Recalls Sunflower Kernels in Salad Kits

    Garden Fresh Foods is recalling sunflower kernels in specific salad kits due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods Broccoli Raisin Salad Kit #2081, Net Wt 3.38 lbs, 1.53 kg, 0 00 11596 42081 3.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1363-2016·2016-07-27

    PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 15 bags of compounded morphine and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1763-2016·2016-07-27

    Organic Vegetable Medley Recalled for Potential Listeria Contamination

    CRF Frozen Foods is recalling Organic Premium Blend Vegetable Medley with Shelled Edamame due to potential Listeria monocytogenes contamination.

    Product
    Frozen Organic Premium Blend Vegetable Medley with Shelled Edamame, Organic by Nature brand, net wt. 5 lb. The UPC is 8 46358 00065 7. Product label bears cooking instructions and listed as: MICROWAVE 1. Pour one quarter contents of bag into a microwave safe dish with…
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Drugs)·D-1404-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates

    PharMEDium Services, LLC is recalling 85 cassettes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1384-2016·2016-07-27

    PharMEDium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

    PharMEDium Services, LLC is recalling 1,577 syringes of compounded hydrocodone and bupivacaine injectable drugs nationwide due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1693-2016·2016-07-27

    Clif Bar Nuts & Seeds Energy Bar Recalled for Listeria Risk

    Clif Bar is recalling Nuts & Seeds energy bars because a supplier notified the firm that sunflower kernels may be contaminated with Listeria monocytogenes.

    Product
    CLIF BAR Nuts & Seeds energy bar, 68 g bar. Almonds, Peanuts, Pumpkin Seeds UPC: 7-22252-16101-7; 12 count and 6 count packages INGREDIENTS: Organic Brown Rice Syrup, Organic Rolled Oats, Soy Protein Isolate, Sunflower Seeds, Organic Almonds, Organic Cane Syrup, Organic…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1391-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 17,990 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.

    Product
    2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1717-2016·2016-07-27

    Atkins Nutritionals Recalls Caramel Double Chocolate Crunch Bars Due to Listeria Risk

    Atkins Nutritionals is recalling Caramel Double Chocolate Crunch Bars because they may be contaminated with Listeria monocytogenes from sunflower seeds.

    Product
    Caramel Double Chocolate Crunch Bar 6x5, UPC: 637480035057, Case UPC: 637480039055. Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services, LLC is recalling 555 sterile injectable drug cassettes containing Hydromorphone HCl and Bupivacaine HCl due to the presence of glass particulate matter.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1394-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services is recalling 1,280 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1767-2016·2016-07-27

    Garden Fresh Foods Recalls Sunflower Kernels in Salad Kits

    Garden Fresh Foods is recalling sunflower kernels in specific salad kits due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods, Cool Breeze Salad Kit #2092, Net Wt 6.75 lbs 3,06 kg, 0 01 11596 72092 7.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1385-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services is recalling 30 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1696-2016·2016-07-27

    Clif Bar Sierra Trail Mix Recalled for Listeria Risk

    Clif Bar and Company is recalling Sierra Trail Mix bars due to potential Listeria monocytogenes contamination in sunflower kernels.

    Product
    CLIF BAR Sierra Trail Mix/ Melange Montagnard Sierra; 68 g bar; 12 ct packages UPC: 7-22252-12115-8 Canadian distribution only. INGREDIENTS: BROWN RICE SYRUP*, SOY RICE CRISPS (SOY PROTEIN ISOLATE, RICE FLOUR, BARLEY MALT EXTRACT), ROLLED OATS*, RAISINS*, PEANUTS*…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1365-2016·2016-07-27

    Pharmedium Recalls Bupivacaine HCl Bags Due to Glass Particulate Matter

    Pharmedium Services, LLC is recalling 8,581 bags of 0.125% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

    Product
    0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V561000·2016-07-27

    Jayco Recalls 2016-2017 Precept and Alante Motorhomes for Seat Defect

    Jayco is recalling 2016-2017 Precept and Alante motorhomes because the driver's seat may loosen and detach from the base, increasing the risk of a crash.

    Product
    JAYCO — JAYCO PRECEPT, ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1740-2016·2016-07-27

    Rucker's Recalls Cajun Hot Mix Due to Listeria Contamination

    Rucker's Wholesale & Service Co. is recalling 3,915 bags of Cajun Hot Mix because sunflower kernels are contaminated with Listeria monocytogenes.

    Product
    Cajun Hot Mix 6 OZ. packaged in clear plastic bags with sticker label. This product has multiple brands. All brands are under the same UPC 052545002681. Brand names include Big R. Stores, Bomgaar's, C-A-L Ranch Store's, Coastal, Family Choice, Fin Feather Furn Outfitter's…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1744-2016·2016-07-27

    Rucker's Recalls Cajun Hot Mix Due to Listeria Contamination

    Rucker's Wholesale & Service Co. is recalling 24,112 bags of Cajun Hot Mix because sunflower kernels are contaminated with Listeria monocytogenes.

    Product
    CAJUN HOT MIX 8 OZ. packaged in a clear plastic bag with sticky label under the UPC number 052545022689, and several brand names, including ATWOOD'S RANCH & HOME, BASS PRO SHOP'S UNCLE BUCK'S, BIG R STORE'S, CABELA'S CLASSIC'S, CABELA'S OUTFITTER CLASSIC, FARM & HOME SUPPLY, F &…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1368-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulates

    PharMEDium Services, LLC is recalling 2,874 bags of 0.25% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 10 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1399-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services, LLC is recalling 21 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1434-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services is recalling 650 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1409-2016·2016-07-27

    Pharmedium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

    Pharmedium Services is recalling 435 syringes of compounded hydrocodone and bupivacaine due to glass particulate contamination.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1376-2016·2016-07-27

    PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services, LLC is recalling 25 bags of compounded Sufentanil and Bupivacaine injectable solution because the active ingredient was contaminated with glass particulate.

    Product
    1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is voluntarily recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1727-2016·2016-07-27

    Kellogg Recalls Famous Amos Cookies Due to Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Famous Amos Cookies Double Chocolate Chip because of a potential undeclared peanut allergen resulting from a supplier's flour recall.

    Product
    Famous Amos Cookies Double Chocolate Chip, 12 ct., 12.4 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2234-2016·2016-07-27

    WalkMed Infusion Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2016·2016-07-27

    Encore Medical Recalls Modified Linear Standard and Lateral Neck Trials

    Encore Medical is recalling 14 neck trial sets because a retaining ring component can disassemble from the body of the neck.

    Product
    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1764-2016·2016-07-27

    Parker Products Recalls Choco Praline Graham Blend for Undeclared Peanuts

    Parker Products, Inc. is recalling 725 cases of 3015 Choco Praline Graham Blend due to undeclared peanuts. The product was distributed in Ohio and California.

    Product
    3015 Choco Praline Graham Blend Net Weight: 25 lbs/11.34 kgs
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1723-2016·2016-07-27

    Kellogg Recalls Keebler Frozen Graham Snacks Cinnamon for Undeclared Peanut

    Kellogg Company is voluntarily recalling Keebler Frozen Graham Snacks Cinnamon due to the potential for undeclared peanut allergen resulting from a supplier's flour recall.

    Product
    Keebler Frozen Graham Snacks Cinnamon, 4 ct., 12.7 oz. ; and cups 2.2 oz. 10 ct., and cups 2.2 oz. 8 ct.
    Category
    Food
    Distribution
    46 states
  • HighCPSC·16762·2016-07-27

    Emson Recalls UComfy Neck and Shoulder Heat Wraps Due to Burn Hazard

    Emson is recalling UComfy Neck and Shoulder Heat Wraps because they can overheat and cause burns. Consumers should stop using the product and contact Emson for a free replacement.

    Product
    UComfy Neck and Shoulder Heat Wrap
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1732-2016·2016-07-27

    Keebler Mini Sandies Shortbread Cookies Recalled for Undeclared Peanut

    Kellogg Company is recalling Keebler Mini Sandies Shortbread cookies due to potential undeclared peanut allergen from a flour supplier issue.

    Product
    Keebler Mini Sandies Shortbread cookies, 100 ct., 1.0 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1724-2016·2016-07-27

    Kellogg Recalls Keebler Fudge Cookies Due to Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Keebler E. L. Fudge Double Stuffed Sandwich Cookies because they may contain undeclared peanut.

    Product
    Keebler E. L. Fudge Double Stuffed Sandwich Cookies, 12 ct., 12 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1736-2016·2016-07-27

    Kellogg Recalls Gripz Variety Packs Due to Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Gripz Variety On the Go Packs because they may contain undeclared peanut, a common allergen, due to a supplier's flour recall.

    Product
    Gripz Variety On the Go Pack, 14 pack, 12.6 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-1733-2016·2016-07-27

    Kellogg Recalls Famous Amos Chocolate Chip Cookies for Undeclared Peanut

    Kellogg Company is voluntarily recalling Famous Amos Chocolate Chip Cookies due to potential undeclared peanut allergen from a flour supplier issue.

    Product
    Famous Amos Cookies Chocolate Chip, 12 ct., 12.4 oz.; and 2.7 oz. cup
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2221-2016·2016-07-27

    WalkMed Infusion Recalls Spike Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling 12-inch Microbore Spike Sets due to the potential presence of particulate matter in or on the devices.

    Product
    Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1737-2016·2016-07-27

    Kellogg Recalls Keebler Animal Totes for Undeclared Peanut Allergen

    Kellogg Company is voluntarily recalling Keebler Animal Totes due to a potential undeclared peanut allergen resulting from a supplier's flour recall.

    Product
    Keebler Animal Totes, bulk tote 400 lb.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Drugs)·D-1364-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate

    PharMEDium Services is recalling 4,081 bags of 0.1% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2016·2016-07-27

    WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence

    WalkMed Infusion is voluntarily recalling Triton Administration Sets because they may contain particulate matter. The recall affects 383 cases distributed nationwide.

    Product
    T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter on or in the devices.

    Product
    T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2016·2016-07-27

    Parker Trach-Vac Endotracheal Tubes Recalled Due to Tube Kinking During Use

    Parker Medical is voluntarily recalling Trach-Vac Endotracheal Tubes because they may kink during use, potentially affecting patient ventilation.

    Product
    Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1738-2016·2016-07-27

    Kellogg Recalls Keebler 5 Flavor Mod for Undeclared Peanut

    Kellogg Company is voluntarily recalling Keebler 5 Flavor Mod snack items because they may contain undeclared peanut. The recall stems from a supplier's recall of flour.

    Product
    Keebler 5 Flavor Mod
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2222-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1721-2016·2016-07-27

    Kellogg's Special K Mini Brownies Recalled for Undeclared Peanut

    Kellogg Company is voluntarily recalling Special K Mini Brownies Blondie due to potential undeclared peanut from a flour supplier issue.

    Product
    Kellogg's Special K Mini Brownies Blondie, 6 ct, 4.44 oz.
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2254-2016·2016-07-27

    Roche Recalls cobas EGFR Mutation Test V2 Due to False Negatives

    Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.

    Product
    cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2235-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of T100-000VF IV sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16232·2016-07-27

    Novel Laboratories Recalls Zolpidem Tartrate Tablets for Packaging Defect

    Novel Laboratories is recalling Zolpidem Tartrate sublingual tablets because the packaging fails to meet child-resistant closure requirements, posing a risk of poisoning to children.

    Product
    Zolpidem Tartrate Sublingual tablets
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1730-2016·2016-07-27

    Kellogg Recalls Keebler Grahams Crackers Honey Due to Undeclared Peanut

    Kellogg Company is voluntarily recalling Keebler Grahams Crackers Honey in 200-count and 30-count cases because of potential undeclared peanut.

    Product
    Keebler Grahams Crackers Honey 200 CT, 2-pk, 0.49 oz., and 30 CT 5.33 oz.,10 Lb. cases
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2226-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion, LLC is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2016·2016-07-27

    WalkMed Infusion Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling T100-000F IV sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2016·2016-07-27

    WalkMed Recalls IV Administration Sets Due to Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of IV sets with 0.22 micron filters due to the potential presence of particulate matter in or on the devices.

    Product
    T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2016·2016-07-27

    WalkMed Infusion Recalls Triton Administration Sets Due to Particulate Presence

    WalkMed Infusion is voluntarily recalling Triton Administration Sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2016·2016-07-27

    Biomet Recalls TSP Hip Fracture Plating System Due to Screw Fracture Risk

    Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System because screws may fracture during implantation, potentially leaving a foreign body in the patient.

    Product
    TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2206-2016·2016-07-27

    RayStation Radiation Therapy Software Recalled for Incorrect Biological Goal Evaluation

    RaySearch Laboratories is recalling RayStation radiation therapy software versions 3.0 through 5 due to incorrect biological clinical goal values for adapted plans.

    Product
    RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2231-2016·2016-07-27

    WalkMed Recalls IV Sets Due to Potential Particulate Presence

    WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.

    Product
    T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2250-2016·2016-07-27

    Centurion Convenience Kits Recalled Due to Defective Medtronic Light Glove

    Centurion is recalling 483 convenience kits containing Medtronic light gloves with potential splits or holes that could transfer microorganisms to patients.

    Product
    Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
    Category
    Medical Device
    Distribution
    6 states

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