FDA-Device2024-01-17Class II
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis US Corp
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.
Sold states
US: NC, WV, TN, MS, MI, OH, CA
Affected count
50 units
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0674-2024Don't want to check this manually?
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