PlainRecalls
FDA Devices Moderate Class II Ongoing

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Reported: December 20, 2023 Initiated: October 19, 2023 #Z-0520-2024

Product Description

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Reason for Recall

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.

Details

Recalling Firm
Meridian Bioscience Inc
Units Affected
201 Cases
Distribution
Nationwide Foreign: Italy
Location
Cincinnati, OH

Frequently Asked Questions

What product was recalled?
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012. Recalled by Meridian Bioscience Inc. Units affected: 201 Cases.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0520-2024.