RecallRadar

FDA Device recall Z-0519-2024

Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Ca…

On 2023-12-20 the FDA classified a Class II recall of Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Ca… by Meridian Bioscience, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0519-2024
ClassificationClass II
Statusongoing
Initiated2023-10-19
Published2023-12-20
Last updated2026-09-13 11:56 UTC
CompanyMeridian Bioscience
DistributionUS

Product

Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

Reason

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.

Identifiers

code_infoUDI-DI: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0519-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.