Recall Z-0675-2024 ยท MGB Device, Hemostasis, Vascular
Cordis US Corp
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
| Date | Jan 5, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct. |
| Root cause | Labeling Change Control |
| Action | Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT. |
| Quantity | 70 units |
| Distribution | US: NC, WV, TN, MS, MI, OH, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.