FDA-Device2013-06-12Class II
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.
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
7960 units (796 boxes)
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1495-2013Don't want to check this manually?
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