BEUDAMED
    FDA Enforcement Class III Terminated

    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

    Recall: Z-1077-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1077-2015
    Event ID
    70332
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    December 22, 2014
    Classification Date
    February 10, 2015
    Termination Date
    May 5, 2015
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

    Reason

    A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.

    Code Info

    Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

    Distribution

    Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

    Quantity

    1530 units (170 cases)