BEUDAMED
    FDA Enforcement Class II Terminated

    T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

    Recall: Z-1810-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1810-2012
    Event ID
    61848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 20, 2012
    Initiation Date
    June 1, 2012
    Classification Date
    June 14, 2012
    Termination Date
    April 14, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

    Reason

    The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

    Code Info

    Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots

    Distribution

    Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND

    Quantity

    16, 846 (last 3 years) 35,492 all years