FDAClass IIDecember 20, 2023

Para-Pak Zn-PVA/10% Formalin-for the routine collection recall

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

Why was Para-Pak Zn-PVA/10% Formalin-for the routine collection 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025

Product
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites…
Recalling firm
Meridian Bioscience Inc
Quantity
201 Cases
Distribution
Nationwide Foreign: Italy
Recall date
December 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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