Meridian Bioscience Inc Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Brand
Meridian Bioscience Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 50885380144859* *The UDI information for this product is maintained by Cardinal Health. Lot Numbers: 510020Q Expiration Date: 09/15/2030
Meridian Bioscience Inc is recalling Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, due to Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026