Cordis US Corp MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Brand
Cordis US Corp
Lot Codes / Batch Numbers
UDI/DI 10862028000403, Lot numbers: F2322902
Products Sold
UDI/DI 10862028000403, Lot numbers: F2322902
Cordis US Corp is recalling MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral ve due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MI, MS, NC, OH, TN, WV
Page updated: Jan 10, 2026