Device product
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, 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.
Z-1498-2013
Product summary
- Event
- Event 65321
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,980 units ( 398 boxes)
- Official record key
device-enforcement:Z-1498-2013
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: 1005098, 1010228, 1012337, 1105367
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach in the sterile barrier