Cordis MYNXGRIP Vascular Closure Device Carton Labeling Error
Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II FDA recall involving a labeling error on carton packaging only. No injuries or illnesses have been reported. Individual device labels are correct, providing the primary safeguard against misuse. This constitutes a minor labeling error meeting the Moderate severity threshold.
Plain-English summary
Cordis US Corp recalled 70 units of MYNXGRIP 6F/7F vascular closure devices (REF MX6721, UDI/DI 10862028000403) due to incorrect carton labeling. Carton boxes containing 10 units were mislabeled for products from two affected lots.
The carton from lot F2322902 (MynxGrip 5F, Item MX5021) was labeled as lot F2322903 (MynxGrip 6/7F), and cartons from lot F2322903 were labeled as lot F2322902. However, the primary label on individual devices is correct, allowing proper product identification at the point of use.
The recalled devices were distributed to healthcare facilities in North Carolina, West Virginia, Tennessee, Mississippi, Michigan, Ohio, and California. Healthcare providers should verify lot numbers against shipping documentation and consult individual device labels, which remain accurate, to ensure correct product identification and use.
The recalled product
- Product
- MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
- Manufacturer
- Cordis US Corp
- Hazard
- Affected units
- 70
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: F2322903
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cordis US Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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