Official recall record
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-28
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10862028000403
- Brand on record
- Cordis US Corp
- Product category
- Medical Device
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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