FDA Device recall Z-0520-2024
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal pa…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal pa… by Meridian Bioscience, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0520-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
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.
Identifiers
| code_info | UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0520-2024%22
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