Recall Z-0521-2024 ยท FMH Container, Specimen, Sterile
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
| Date | Dec 8, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. |
| Root cause | 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 replacemen |
| Quantity | 38 Cases |
| Distribution | Nationwide Foreign: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792710 | PARA-PAK CLEAN VIAL Meridian Diagnostics, Inc., Jan 28, 1980 |