Recall Z-1510-2025 ยท NIO Stent, Iliac
Cordis US Corp
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
| Date | Apr 3, 2025 (initiated Mar 4, 2025) |
| Status | Open, Classified |
| Reason | product mix-up; Vascular stent labeled as one size but contains a different size. |
| Root cause | Employee error |
| Action | On March 3, 2025, Cordis issued an "URGENT MEDICAL DEVICE RECALL" notification via FedEx. Cordis asked consignees to take the following actions: 1. Read this Urgent Medical Device Recall letter. 2. Immediately check your inventory for any units from the affected lot in your possession. Identify and quarantine any units from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 3. Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the a |
| Quantity | 20 units |
| Distribution | US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.