FDA Device recall Z-0521-2024
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens cont…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens cont… by Meridian Bioscience, citing due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0521-2024 |
| 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
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Reason
Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
Identifiers
| code_info | UDI-DI: 50885380144859* *The UDI information for this product is maintained by Cardinal Health. Lot Numbers: 510020Q Expiration Date: 09/15/2030 |
|---|
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-0521-2024%22
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