Device product
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Z-0756-2017
Product summary
- Firm
- Covidien LLC
- Event
- Event 75481
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,187,100 Units
- Official record key
device-enforcement:Z-0756-2017
Official wording
Reason: Sterility of the outer surface of the container compromised due to packaging defect.
Code information: All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
Distribution pattern: Nationwide Foreign: Japan
Derived failure modes
-
Labeling or packaging
packaging defect
-
Sterility assurance
Sterility of the outer surface of the container compromised due to packaging defect