Recall Z-0754-2024 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cardinal Health 200, LLC
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
| Date | Jan 18, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. |
| Root cause | Process control |
| Action | Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/21/2023 via overnight delivery. The notice explained the issue with the product and requested the consignee post a copy of Attachment A in the storeroom and clinical areas which provides the following information: Please take the following actions: "" Inspect liner for misalignment with the outer hard canister during setup. The misalignment can be seen visually during setup as the liner not sitting properly within the canister and can be felt by a springing back of the liner from the outer ca |
| Quantity | 3505730 units |
| Distribution | US, Canada, Australia and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.