BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0520-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0520-2024
    Event Number
    93350
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    IGG
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 19, 2023
    Posted
    December 8, 2023
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    Description

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

    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.

    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

    Distribution

    Nationwide Foreign: Italy

    Quantity

    201 Cases