Update On Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

    November 19, 2019 The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. In our previous letter to health care providers, the FDA informed providers about reports of Maquet/Datascope IABP devices shutting…

    Device Failure Associated with Getinge’s Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

    November 1, 2018 Dear Cardiologists, Cardiothoracic Surgeons, Anesthesiologists, Nurses, Critical Care Specialists and Biomedical Engineers: We are writing to inform you that the FDA is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. These devices are used on critically-ill patients in health care facilities, including…

    Select Varieties of Breakstone’s Cottage Cheese are Voluntarily Being Recalled Due to Potential Presence of Foreign Material

    Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 15, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of plastic and metal Company Name: Kraft Heinz Foods Company Brand Name: Brand Name(s) Breakstone’s Product Description: Product Description Cottage Cheese Company Announcement Select varieties of Breakstone’s Cottage Cheese…

    Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

    Summary Company Announcement Date: November 15, 2019 FDA Publish Date: November 15, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Company Name: GSMS, Inc. Brand Name: Brand Name(s) GSMS Incorporated Product Description: Product Description Ranitidine HCl 150mg and 300mg Capsules Company Announcement…

    Is It a Cold or the Flu? Prevention, Symptoms, Treatments

    Warning Signs of Severe Flu Seek medical care if you aren’t getting any better. Signs of trouble can include: In children: Fast breathing or trouble breathing Bluish skin color Not drinking enough fluids Not waking up or not interacting Being so irritable that the child does not want to be held Flu-like symptoms improve but…

    Natural Grocers Issues Recall on Organic Soybeans Due to Mold

    Summary Company Announcement Date: November 13, 2019 FDA Publish Date: November 13, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to contain mold Company Name: Vitamin Cottage Natural Food Markets, Inc. Brand Name: Brand Name(s) Natural Grocers Product Description: Product Description Organic Soybeans Company Announcement Vitamin Cottage Natural Food Markets,…

    Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product

    Summary Company Announcement Date: November 13, 2019 FDA Publish Date: November 13, 2019 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Due to unapproved active ingredient (sildenafil) Company Name: Nature’s Rx Brand Name: Brand Name(s) Silver Bullet Product Description: Product Description Male Enhancement Capsules Company Announcement Nature’s Rx is voluntarily recalling lot: 01251ZX1,…

    The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

    Date Issued: November 28, 2017 Audiences: People taking or considering taking biotin, vitamin B7, supplements Physicians and other health care providers who order lab tests Lab personnel Lab test developers Specialties: All physicians and health care providers Product: Many lab tests use biotin technology due to its ability to bond with specific proteins which can…

    Kettle Cuisine Issues Allergy Alert on Undeclared Fish and Wheat in Marketside Creamy Cauliflower Parmesan Soup 16oz

    Summary Company Announcement Date: November 12, 2019 FDA Publish Date: November 13, 2019 Product Type: Food & BeveragesSoup Reason for Announcement: Recall Reason Description Undeclared fish and wheat Company Name: Kettle Cuisine Brand Name: Brand Name(s) Marketside Product Description: Product Description Marketside Brand Creamy Cauliflower Parmesan Soup Company Announcement Kettle Cuisine of Lynn, MA is…