FDA-Device2013-06-12Class II
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; 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.
Stryker Instruments Div. of Stryker Corporation
Hazard
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
Sold states
USA Nationwide Distribution
Affected count
25,770 units (2,577 boxes)
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1499-2013Don't want to check this manually?
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