Z-0520-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 19, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 201 Cases
Product Description
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Reason for Recall
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.
Distribution Pattern
Nationwide Foreign: Italy
Code Information
UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025