Device product
Manometer, 550 ml three-Way Stopcock; STERILE;
Z-1421-2018
Product summary
- Event
- Event 76620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,240 units
- Official record key
device-enforcement:Z-1421-2018
Official wording
Reason: The integrity of the sterile packaging is potentially compromised.
Code information: Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962
Distribution pattern: Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
Derived failure modes
-
Sterility assurance
sterile packaging is potentially compromised