FDA recall Z-0675-2024

Cordis US Corp · Class II · device

Product

MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites

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

Key facts

Status: Ongoing
Initiation date: 2023-11-28
Report date: 2024-01-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2024