Namic and Medline Guidewires and Syringes Recalled for Regulatory Issues

Summary

Medline Industries, LP has recalled approximately 629,606 guidewires, control syringes, and specialized medical packs sold under the Medline and Namic brands. The recall was issued because the 510(k) regulatory clearances for these products have been rescinded, meaning their safety and effectiveness have not been confirmed by the FDA for clinical use. No injuries or incidents have been reported, but hospitals and clinics should immediately stop using these components and contact the manufacturer or distributor to arrange for their return or replacement.

Risk

The regulatory clearance for these guidewires and syringes was removed, meaning the manufacturer has not established that the devices meet safety and performance standards for surgical and catheterization procedures. Use of unvalidated medical devices could lead to patient injury or procedure complications.

Additional Information