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Recall Observatory FDA recall evidence

Device product

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

Z-0675-2024

November 28, 2023

Class II

Product summary

Firm
Cordis US Corp
Event
Event 93617
Status
Ongoing
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-0675-2024

Official wording

Reason: 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.

Code information: UDI/DI 10862028000403, Lot numbers: F2322903

Distribution pattern: US: NC, WV, TN, MS, MI, OH, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.