BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1471-2022
    Event ID
    90516
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - SPT
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2022
    Initiation Date
    June 6, 2022
    Classification Date
    July 27, 2022
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757, United States

    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

    Code Info

    Lot Code: a. Model Number DYNJ36725B, Lot codes: 19UBB149, b. Model Number DYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567

    Distribution

    US Nationwide distribution.

    Quantity

    288 units