Recall Z-0739-2024 ยท DRS Transducer, Blood-Pressure, Extravascular
Smiths Medical Asd Inc
Medex LOGICAL CATH LAB KIT, List Number M20754
| Date | Jan 17, 2024 (initiated Nov 10, 2023) |
| Status | Open, Classified |
| Reason | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/10/23 was sent to customers. Required Actions for Users: 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical7166@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or it has already been |
| Quantity | 31,685 total |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820355 | DISPOSABLE DIAPHRAGM DOMES Medex, Inc., Mar 4, 1982 |