Z-0519-2024Class II

Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens...

Name: Z-0519-2024 Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens...
Creator: Meridian Bioscience Inc
Published: 2023-10-19
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2023-10-19 / Open, Classified / root cause: manufacturing process

FDA source

Meridian Bioscience Inc began a recall of Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312 on 2023-10-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0519-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-19
Posted: 2023-12-08
Recalling firm: Meridian Bioscience Inc
Product: Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Product code: FMH Container, Specimen, Sterile
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Meridan issued Urgent Medical Device Correction letters via email on 10/19/23 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: Identify and segregate any remaining inventory. REQUIRED ACTIONS FOR PARA-PAK CLEAN VIAL, CATALOG 900312, LOT 509940Q: " Identify and segregate any remaining inventory. " Discard remaining Inventory of Para-Pak Clean Vial, Catalog 900312, Lot 509940Q in accordance with local, state, and/or federal regulations. Record quantity discarded. o Contact Meridian Technical Support at 1-800-343-3858 to coordinate product replacement activities. " Complete and return the Customer Notification Form. This will indicate notification of this field correction. Complete this form even if you have no remaining inventory. REQUIRED ACTIONS FOR PARA-PAK Zn-PVA/10% FORMALIN, CATALOG 301012, LOT 509130Q: " Identify and segregate any remaining inventory. " For remaining inventory of Para-Pak Zn-PVA/10% Formalin, Catalog 301012, Lot 509130Q, inspect each individual vial set for signs of leakage. o Leakage would be able to be visually observed through inspection of the Ziplock-style bag containing the two vials of preservatives. Signs of leakage include identification of preservative outside of the plastic vials or at the bottom of the Ziplock-style bag. DO NOT remove vials that exhibit leaking from the Ziplock-style bag. Handle with care to prevent direct contact of the preservative with the skin or eyes. o Record the quantity of 2 vial sets that demonstrated signs of leakage. " Discard the remaining inventory of Para-Pak Zn-PVA/10% Formalin, Catalog 301012, Lot 509130Q in accordance with local, state, and/or federal regulations. Record quantity discarded. o Contact Meridian Technical Support 1-800-343-3858 to coordinate product replacement activities. " Complete and return the Customer Notification Form. This will indicate notification of this field correction. Complete this form even if you have no remaining invento
Quantity in commerce: 571 Cases
Distribution: Nationwide Foreign: Italy
Product codes and lots: UDI-DI: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0519-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0519-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08
Z-0520-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08
Z-0521-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-08

Product code FMH

K792710Class IPara-Pak Clean VialMeridian Diagnostics, Inc. / cleared 1980-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)