BEUDAMED
    FDA Enforcement Class II Terminated

    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

    Recall: Z-1507-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1507-2018
    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

    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

    Reason

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

    Code Info

    Lot numbers: 17061816, 17061836, 17061839, 17061853, 17071921, 17072017, 17102944, 17102948, 17113081, 17113141, 17113194

    Distribution

    US Nationwide and Ireland, Japan, South Korea, UK

    Quantity

    34570 total products