BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3079-2017
    Event ID
    77633
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Master & Frank (Pinghu) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 6, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    August 28, 2017
    Address
    2 No. 2000 Xingping Road, N/A, Hangzhou, N/A, N/A, 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.

    Code Info

    Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH

    Distribution

    Domestic: IL.

    Quantity

    2,160 units