MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
- Company
- Cordis Us Corp
- Recall Initiated
- November 28, 2023
- Posted
- January 5, 2024
- Recall Number
- Z-0675-2024
- Quantity
- 70 units
- Firm Location
- Miami Lakes, FL
Reason for Recall
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.
Distribution
US: NC, WV, TN, MS, MI, OH, CA
Lot / Code Info
UDI/DI 10862028000403, Lot numbers: F2322903
Root Cause
Labeling Change Control
Action Taken
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.