Device product
Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.
Z-1067-2020
Product summary
- Event
- Event 84530
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1067-2020
Official wording
Reason: Incomplete seals on the sterile package may compromise the sterility
Code information: 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 2018110690 17070 AI OR CARDIAC STERILE KIT 2018121490 3703ST STERILE PATHOLOGY CONTAINER 2019031990 3706ST STERILE CONTAINER 165 OZ. 2019041290
Distribution pattern: Nationwide Foreign: GHANA
Derived failure modes
-
Sterility assurance
seals on the sterile package may compromise the sterility