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Class 2 Device Recall ParaPak ZnPVA/10 Formalin |
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Date Initiated by Firm |
October 19, 2023 |
Date Posted |
December 08, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0520-2024 |
Recall Event ID |
93350 |
510(K)Number |
K792705
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Product Classification |
Formaldehyde (formalin, formol) - Product Code IGG
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Product |
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 |
UDI-DI: 00840733101250
Lot Numbers: 509130Q
Expiration Date: 08/11/2025 |
Recalling Firm/ Manufacturer |
Meridian Bioscience Inc 3471 River Hills Dr Cincinnati OH 45244-3023
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For Additional Information Contact |
Heather Capito 800-343-3858
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Manufacturer 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.
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FDA Determined Cause 2 |
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 |
201 Cases |
Distribution |
Nationwide
Foreign: Italy |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = IGG and Original Applicant = MERIDIAN DIAGNOSTICS, INC.
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