BEUDAMED
    FDA Recall Open, Classified

    Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

    Recall: Z-0711-2024 · Initiated November 29, 2023

    Recall

    Recall Number
    Z-0711-2024
    Event Number
    93560
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    FYA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 29, 2023
    Posted
    January 11, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

    Reason

    Surgical gowns were manufactured with the wrong sleeve.

    Action

    The recalling firm issued letters dated 11/29/2023 via email and first class mail on 11/29/2023. The letter explained the reason for recall and provided required actions. Those actions were to (1) Immediately check the stock for the affected item and lot numbers which can be located within the recall portal; (2) Use the link and information in the letter to complete the response form; and (3) Destroy any affected inventory and the recalling firm will issue a credit. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify the downstream company.

    Distribution

    Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.

    Quantity

    2,100 gowns