Skip to content
Recall Observatory FDA recall evidence

Device product

Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312

Z-0521-2024

October 19, 2023

Class II

Product summary

Firm
Meridian Bioscience Inc
Event
Event 93350
Status
Ongoing
Classification
Class II
Quantity
38 Cases
Official record key
device-enforcement:Z-0521-2024

Official wording

Reason: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

Code information: UDI-DI: 50885380144859* *The UDI information for this product is maintained by Cardinal Health. Lot Numbers: 510020Q Expiration Date: 09/15/2030

Distribution pattern: Nationwide Foreign: Italy

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect