BEUDAMED
    FDA Enforcement Class II Terminated

    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

    Recall: Z-1506-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1506-2018
    Event ID
    79779
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    February 23, 2018
    Classification Date
    April 24, 2018
    Termination Date
    May 23, 2019
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

    Reason

    Separation of material layers may occur, causing a potential risk of exposure to contaminants.

    Code Info

    Lot numbers: 17061810, 17061814, 17071878, 17071903, 17071918, 17071920, 17071949, 17071960, 17071970, 17071974, 17071997, 17072002, 17072006, 17072016, 17102897, 17102926, 17102936, 17102942, 17102956, 17102971, 17102994, 17102996, 17113021, 17113034, 17113037, 17113084, 17113133, 17113191, 17113197, 17113203, 17113221

    Distribution

    US Nationwide and Ireland, Japan, South Korea, UK

    Quantity

    34570 total products