BEUDAMED
    FDA Recall Terminated

    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

    Recall: Z-1505-2018 · Initiated February 23, 2018

    Recall

    Recall Number
    Z-1505-2018
    Event Number
    79779
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FYA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2018
    Terminated
    May 23, 2019
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment

    Reason

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

    Action

    On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments at 866-521-2762, or email to [email protected]. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification; 4) If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF; 5) If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you and should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Customer with questions or concerns may call (800)253-3210.

    Distribution

    US Nationwide and Ireland, Japan, South Korea, UK

    Quantity

    34570 total products