BEUDAMED
    FDA Enforcement Class II Terminated

    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

    Recall: Z-1235-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1235-2015
    Event ID
    70466
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zipline Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 11, 2015
    Initiation Date
    February 5, 2015
    Classification Date
    March 2, 2015
    Termination Date
    April 10, 2015
    Address
    747 Camden Ave Ste A, N/A, Campbell, CA, 95008-4147, United States

    Description

    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.

    Reason

    The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

    Code Info

    Lot 1002750, Exp 2016-09

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

    Quantity

    3109 devices, total all model numbers