BEUDAMED
    FDA Recall Terminated

    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.

    Recall: Z-2066-2019 · Initiated May 3, 2019

    Recall

    Recall Number
    Z-2066-2019
    Event Number
    82940
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 3, 2019
    Posted
    August 12, 2019
    Terminated
    March 1, 2021
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.

    Reason

    The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.

    Action

    The firm notified its distributor, Medline, of the recall via Urgent Product Recall Notice. The distributor was asked to identify all inventory within its possession and to cease distribution immediately. The distributor was also asked to forward a copy of the notice to any customers to whom the product may have been further distributed. Medline notified customers in a letter dated March 20, 2019, titled "VYAIRE MEDICAL SUB-RECALL IMMEDIATE ACTION REQUIRED". Customers were instructed to do the following: 1. Immediately check your stock for the specific kit number and the affected kit lot number (attached list). Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the recalled enFlow Disposable Cartridge components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to [email protected] or fax 866-767-1290. Customers with questions should contact the firm at 1-866-359-1704.

    Distribution

    One distributor located in Illinois.

    Quantity

    4,680 kits