Cardinal Health Stool Transportation System Recalled for Vial Leakage
Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with a manufacturing defect creating a genuine risk-of-harm scenario. The leakage hazard in specimen transportation vials poses potential exposure to parasites and biological materials, affecting laboratory and medical personnel. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Meridian Bioscience Inc is recalling the Cardinal Health Clean Stool Transportation System (Catalog Number CHB900312) due to a manufacturing defect affecting certain Para-Pak vials. The system is used for collection, transportation, preservation, and examination of stool specimens containing intestinal parasites.
The recall involves 38 cases with Lot Number 510020Q and an expiration date of 09/15/2030 (UDI-DI: 50885380144859). The affected product was distributed nationwide in the United States and internationally to Italy.
The vial leakage defect creates a risk of exposure to specimen contents during collection, transportation, and examination. Users of the affected product should contact Meridian Bioscience Inc or Cardinal Health for recall information and options.
The recalled product
- Product
- Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
- Manufacturer
- Meridian Bioscience Inc
- Hazard
- Affected units
- 38
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Meridian Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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