Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
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 an FDA Class II recall involving a manufacturing defect that creates a risk of biological hazard exposure through specimen leakage. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product with no reported injury and a theoretical hazard receives a score of 3 (High).
Plain-English summary
Meridian Bioscience Inc. is recalling Para-Pak Zn-PVA/10% Formalin stool specimen collection and preservation vials (Catalog Number 301012, Lot 509130Q). The recall affects 201 cases distributed nationwide and in Italy.
The vials contain a manufacturing defect that may cause increased risk of leakage. This poses a risk of incidental exposure to biological hazards associated with direct contact with patient specimens.
This recall affects laboratory personnel and healthcare workers who collect and handle stool specimens using these vials. Healthcare facilities and laboratories should stop using affected vials and contact Meridian Bioscience for return or replacement instructions. The affected lot (509130Q) has an expiration date of August 11, 2025.
The recalled product
- Product
- Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
- Manufacturer
- Meridian Bioscience Inc
- Hazard
- Affected units
- 201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025
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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