Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a carton labeling error; individual device labels remain correct, limiting risk to lot-tracking confusion rather than functional or safety defects.
Plain-English summary
Cordis US Corp is recalling MYNXGRIP 5F (REF MX5021) vascular closure devices, which are used to seal femoral arterial and femoral venous access sites. The recall affects approximately 50 units distributed across seven states: North Carolina, West Virginia, Tennessee, Mississippi, Michigan, Ohio, and California.
The recall was initiated due to a labeling error on carton boxes. Boxes from lot F2322902 (MynxGrip 5F, REF MX5021) were incorrectly labeled as lot F2322903 (MynxGrip 6/7F, REF MX6721), and boxes from lot F2322903 were labeled with F2322902. However, the individual device labels are correct and unaffected by this carton-level error.
Patients and healthcare providers with affected devices should verify lot numbers on the carton boxes against the individual device labeling. If the carton labeling does not match the individual device labels, contact Cordis US Corp for guidance. The error affects only the carton labels and does not impact the safety or function of the individual devices.
The recalled product
- Product
- MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
- Manufacturer
- Cordis US Corp
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10862028000403
- Lot numbers: F2322902
Distribution
Distributed in 7 states:
- CA
- MI
- MS
- NC
- OH
- TN
- WV
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