Device product
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Z-1269-2020
Product summary
- Event
- Event 84722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1764 units
- Official record key
device-enforcement:Z-1269-2020
Official wording
Reason: There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Code information: Lot Number 74B1500674
Distribution pattern: Worldwide
Derived failure modes
-
Sterility assurance
packaging to become compromised; thus, the sterility