FDA Recall
Terminated
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Recall: Z-1849-2019
·
Initiated April 30, 2019
Recall
- Recall Number
- Z-1849-2019
- Event Number
- 82894
- Firm
- Stryker GmbH Bohnackerweg 1 Selzach Switzerland
- FEI Number
- 3002807830
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 30, 2019
- Terminated
- September 18, 2020
Description
Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
Reason
The seal integrity of the sterile bag containing the kits may be compromised.
Action
Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
Distribution
The products were distributed US nationwide.
Quantity
1600