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Para-Pak Zn-PVA/10% Formalin-for the routine collection… recallZ-0520-2024 · Meridian Bioscience Inc · initiated Oct 19, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Meridian Bioscience Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

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

Recall details

Recall number
Z-0520-2024
Status
Open, Classified
Initiated by the company
Oct 19, 2023
Posted by the FDA
Dec 8, 2023
Recalling firm
Meridian Bioscience Inc
Quantity
201 Cases
Product code
IGG
FDA submissions
K792705
Distribution
Nationwide Foreign: Italy

Product description

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93350).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page