BEUDAMED
    FDA Recall Open, Classified

    MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

    Recall: Z-3079-2017 · Initiated June 1, 2017

    Recall

    Recall Number
    Z-3079-2017
    Event Number
    77633
    FEI Number
    3006973666
    Product Code
    FYA
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    June 1, 2017
    Address
    Master & Frank (Pinghu) Co., Ltd. 2 No. 2000 Xingping Road Hangzhou China

    Description

    MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

    Reason

    The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

    Action

    Master & Frank Enterprise Co., LTD is working directly with Medline Industries, Inc., on this recall. A written notification was emailed to Medline Industries, Inc. on June 1, 2017 notifying them of the recall and further instructions. Consignee was instructed to quarantine and destroy any recalled product and to respond to the recall communication. The attached recall response form requested that the consignee notify all of their own customers of the recall.

    Distribution

    Domestic: IL.

    Quantity

    2,160 units