Cordis US Corp is recalling approximately 120 units of MynxGrip Vascular Closure Devices, specifically models 5F and 6F/7F, because the external carton boxes for 10-unit packs were mislabeled with the wrong product information. For affected boxes, a carton labeled as the 5F model may actually contain the 6F/7F model, and vice versa. While the individual device packaging inside the box is labeled correctly, the outer box error could lead a healthcare provider to select the wrong size device for a procedure.
If a medical professional relies on the incorrect outer carton label, they may unintentionally use the wrong size vascular closure device during a procedure. This mismatch could lead to complications at the femoral artery or vein access site, potentially causing ineffective sealing or injury to the blood vessel.
Verification and manufacturer contact
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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