Medical Device Recall: MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Cordis US Corp · November 28, 2023
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
States Affected
CA, MI, MS, NC, OH, TN, WV
Quantity Affected
70 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0675-2024
Status: ongoing
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