BEUDAMED
    FDA Recall Terminated

    Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    Recall: Z-1495-2013 · Initiated May 23, 2013

    Recall

    Recall Number
    Z-1495-2013
    Event Number
    65321
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    FYA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 23, 2013
    Posted
    June 6, 2013
    Terminated
    April 14, 2014
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    Reason

    Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

    Action

    Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: [email protected] verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.

    Distribution

    USA Nationwide Distribution

    Quantity

    7960 units (796 boxes)