Device product
Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.
Z-1483-2020
Product summary
- Event
- Event 84943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 669 units
- Official record key
device-enforcement:Z-1483-2020
Official wording
Reason: The sterile packaging has the potential to be compromised.
Code information: Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564
Distribution pattern: International distribution of Kuwait City, Kuwait.
Derived failure modes
-
Sterility assurance
sterile packaging has the potential to be compromised