BEUDAMED
    FDA Enforcement Class II Ongoing

    Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

    Recall: Z-1646-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1646-2023
    Event ID
    92204
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 7, 2023
    Initiation Date
    April 21, 2023
    Classification Date
    May 26, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

    Reason

    The kits were damaged by water.

    Code Info

    (1) Arthroscopy Pack - Lot #22HMD098, Exp. 2024-04-30, UDI/DI (01)10193489956405; (2) Shoulder Pack -Lot #22JMA673, Exp. 2024-01-31, GTIN (01)10193489429817; and (3) Upper Extremity Pack - Lot #HMF900, Exp. 2024-01-31, UDI/DI (01)10193489968453.

    Distribution

    Distribution was made to California. There was no foreign/government/military distribution.

    Quantity

    342 packs (114 packs/product)