Device product
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Z-1422-2018
Product summary
- Event
- Event 76620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 790 units
- Official record key
device-enforcement:Z-1422-2018
Official wording
Reason: The integrity of the sterile packaging is potentially compromised.
Code information: Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017
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