Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Meridian Bioscience Inc: Para-Pak and Cardinal Health Stool Vials Recalled for Potential Leakage

Agency Publication Date: December 8, 2023
Share:
Sign in to monitor this recall

Summary

Meridian Bioscience Inc. is recalling approximately 810 cases of Para-Pak and Cardinal Health stool collection vials due to a manufacturing defect that can cause the plastic vials to leak. These vials are used for the collection and transportation of patient stool specimens for medical examination. If the vials leak, healthcare workers or patients could be accidentally exposed to biological hazards and pathogens contained within the specimens. Because these products are medical diagnostic tools, consumers and healthcare providers should contact the manufacturer immediately for instructions.

Risk

A manufacturing defect in the plastic vials creates a risk of leakage, leading to potential direct skin contact or environmental contamination with infectious biological materials from patient specimens. This exposure presents a risk of infection or illness to those handling the vials.

What You Should Do

  1. Identify your product by checking for Para-Pak Clean Vial (Catalog Number 900312), Para-Pak Zn-PVA/10% Formalin (Catalog Number 301012), or Cardinal Health Clean Stool Transportation System (Catalog Number CHB900312).
  2. Check the packaging for specific affected lot numbers: Lot 509940Q (Exp 09/12/2030) for Para-Pak Clean Vial, Lot 509130Q (Exp 08/11/2025) for Para-Pak Zn-PVA, or Lot 510020Q (Exp 09/15/2030) for Cardinal Health Clean Stool Transportation System.
  3. Verify the UDI-DI numbers on the labels: 00840733101892, 00840733101250, or 50885380144859.
  4. Immediately stop using any vials from the affected lots and secure them in secondary containment to prevent accidental exposure if leaks occur.
  5. Contact Meridian Bioscience Inc at 3471 River Hills Dr, Cincinnati, Ohio, or your healthcare provider for further instructions and potential refund or replacement information.
  6. Contact the FDA for additional questions or to report adverse events at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions for defective medical device

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Para-Pak Clean Vial (571 Cases)
Model / REF:
Catalog Number: 900312
Recall #: Z-0519-2024
Lot Numbers:
509940Q (Exp 09/12/2030)
Date Ranges: Expiration Date: 09/12/2030
Product: Para-Pak Zn-PVA/10% Formalin (201 Cases)
Model / REF:
Catalog Number: 301012
Recall #: Z-0520-2024
Lot Numbers:
509130Q (Exp 08/11/2025)
Date Ranges: Expiration Date: 08/11/2025
Product: Cardinal Health Clean Stool Transportation System (38 Cases)
Model / REF:
Catalog Number: CHB900312
Recall #: Z-0521-2024
Lot Numbers:
510020Q (Exp 09/15/2030)
Date Ranges: Expiration Date: 09/15/2030

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93350
Status: Active
Manufacturer: Meridian Bioscience Inc
Sold By: Cardinal Health; Medical distributors
Manufactured In: United States
Units Affected: 3 products (571 Cases; 201 Cases; 38 Cases)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.