Device product
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Z-1849-2019
Product summary
- Firm
- Stryker GmbH
- Event
- Event 82894
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1600
- Official record key
device-enforcement:Z-1849-2019
Official wording
Reason: The seal integrity of the sterile bag containing the kits may be compromised.
Code information: Lot #s 01404, 01478
Distribution pattern: The products were distributed US nationwide.
Derived failure modes
-
Sterility assurance
sterile bag containing the kits may be compromised