Device product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Z-0520-2024
Product summary
- Event
- Event 93350
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 201 Cases
- Official record key
device-enforcement:Z-0520-2024
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: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025
Distribution pattern: Nationwide Foreign: Italy
Derived failure modes
-
Manufacturing or process control
manufacturing defect