BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 21, 2023

    Recall

    Recall Number
    Z-1646-2023
    Event Number
    92204
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OJH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 21, 2023
    Posted
    May 26, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    The recalling firm issued the recall letter dated 4/21/2023 via email on 4/21/2023. The letter informed the customer the packs were exposed to water, potentially affecting the sterility of the item, and that they should be destroyed for credit. The consignee was requested to immediately check their stock for the affected item number and the lot numbers listed on the recall portal. A link was provided to access the response form to list the quantity of affected product in inventory. Upon completion of the form, the consignee was to destroy the affected product. If the consignee is a distributor or have resold or transferred the product to another company or individual, they were to notify them of this recall communication and have the customer document and destroy any affected product.

    Distribution

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

    Quantity

    342 packs (114 packs/product)