Recall Z-0286-2024 ยท DQO Catheter, Intravascular, Diagnostic
Cordis US Corp
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
| Date | Nov 9, 2023 (initiated Sep 26, 2023) |
| Status | Open, Classified |
| Reason | Non-sterile product labeled as sterile was distributed. |
| Root cause | Process control |
| Action | The account representative for the consignee notified the consignee by phone on September 26, 2023, providing details of the issue and instructed them to quarantine the impacted lot. Cordis then issued an "Urgent MEDICAL DEVICE RECALL" notice to its sole consignee by letter on 09/28/2023. The notice explained the issue, potential risk, and requested the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not have any units from the affected lots in your possession. Identify and set aside any units from the identifie |
| Quantity | 30 devices |
| Distribution | US Distribution to: OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970854 | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER Cordis Corp., Sep 30, 1997 |