Device product
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Z-0519-2024
Product summary
- Event
- Event 93350
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 571 Cases
- Official record key
device-enforcement:Z-0519-2024
Official wording
Reason: Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
Code information: UDI-DI: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030
Distribution pattern: Nationwide Foreign: Italy
Derived failure modes
-
Manufacturing or process control
manufacturing defect