BEUDAMED
    FDA Enforcement Class II Terminated

    Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

    Recall: Z-2231-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2231-2021
    Event ID
    88268
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 1, 2021
    Classification Date
    August 9, 2021
    Termination Date
    March 2, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

    Reason

    The kits may contain an expired component.

    Code Info

    REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.

    Distribution

    US Nationwide distribution in the states of MN, NE, and PA.

    Quantity

    286 kits total for all products