BEUDAMED
    FDA Recall Open, Classified

    Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A

    Recall: Z-1471-2022 · Initiated June 6, 2022

    Recall

    Recall Number
    Z-1471-2022
    Event Number
    90516
    Firm
    MEDLINE INDUSTRIES, LP SPT
    FEI Number
    3000717925
    Product Code
    OFF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 6, 2022
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A

    Reason

    Kits contain leaking bottles of isopropyl alcohol

    Action

    The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations.

    Distribution

    US Nationwide distribution.

    Quantity

    288 units