Z-0519-2024 Class II Ongoing
FDA device recall Z-0519-2024 was initiated by Meridian Bioscience Inc on October 19, 2023 and is designated Class II. 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 sp… The recall status is ongoing. Affected quantity: 571 Cases.
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
- 571 Cases
Product Description
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
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: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030