Device product
Monoject Standard Hypodermic Needle Item code: 8881200029
Z-2037-2019
Product summary
- Event
- Event 82927
- Status
- Completed
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2037-2019
Official wording
Reason: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Code information: Lot Number: 904956
Distribution pattern: Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL
Derived failure modes
-
Manufacturing or process control
Manufacturing defect