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Recall Observatory FDA recall evidence

Device product

Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, 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.

Z-1491-2013

May 23, 2013

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 65321
Status
Terminated
Classification
Class II
Quantity
1,980 units (198 boxes)
Official record key
device-enforcement:Z-1491-2013

Official wording

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

Code information: 1007157, 1103202

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in the sterile barrier