CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled
Meridian Bioscience is recalling Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, distributed nationwide in the US. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0520-2024
- FDA event ID
- 93350
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Oct 2023
- FDA classified
- 8 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 8 Dec 2023 | Classified by FDA | +50 days |
| 20 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Where it was distributed
Nationwide Foreign: Italy
Questions about this recall
Is Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation recalled?
Yes. Meridian Bioscience recalled Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation on 19 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0520-2024.
Why was it 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 lots are affected?
UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025
Where was it sold?
Nationwide Foreign: Italy
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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