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Cordis US Corp recalls MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Recalled January 17, 2024 · FDA recall Z-0675-2024 · Cordis US
Hazard
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. · FDA Class II
Units
70 units
Sold at
US: NC, WV, TN, MS, MI, OH, CA
Description
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.
Product
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Manufacturer(s)
Cordis US Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →