BEUDAMED
    FDA Enforcement Class II Terminated

    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.

    Recall: Z-1076-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1076-2015
    Event ID
    70051
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MAST Biosurgery USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 18, 2015
    Initiation Date
    August 26, 2014
    Classification Date
    February 10, 2015
    Termination Date
    February 24, 2015
    Address
    6749 Top Gun St Ste 108, N/A, San Diego, CA, 92121-4151, United States

    Description

    The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.

    Reason

    The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017.

    Code Info

    LOT 52804 2017-08

    Distribution

    Worldwide Distribution to the country of China.

    Quantity

    49 pieces