Device product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Z-0521-2024
Product summary
- Event
- Event 93350
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 Cases
- Official record key
device-enforcement:Z-0521-2024
Official wording
Reason: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
Code information: UDI-DI: 50885380144859* *The UDI information for this product is maintained by Cardinal Health. Lot Numbers: 510020Q Expiration Date: 09/15/2030
Distribution pattern: Nationwide Foreign: Italy
Derived failure modes
-
Manufacturing or process control
manufacturing defect