FDAFDA · Food and drugs·Recall number Z-0674-2024
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Published January 17, 2024 · Recall initiated: November 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cordis US Corp
- Distributor
- US: NC, WV, TN, MS, MI, OH, CA
- Lot
- UDI/DI 10862028000403, Lot numbers: F2322902
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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