Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Recall
- Recall Number
- Z-0519-2024
- Event Number
- 93350
- Firm
- Meridian Bioscience Inc
- FEI Number
- 1524213
- Product Code
- FMH
- 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 Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
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.
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
Nationwide Foreign: Italy
571 Cases