Cook Medical Product Recall - Multiple Medical Device References

ANSM has been notified of a lot-level recall initiated by Cook Incorporated affecting multiple medical device product lines. The recall involves: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets (distributed in France), Spectrum Central Venous Catheter Sets, pleural drainage devices, NCompass Nitinol Stone Extractors, and CTO-12 Micro Wire Guides. The recall is registered under ANSM reference number R2607073, with supporting documentation dated 02/04/2026 including the manufacturer's notification letter and the complete list of affected lot numbers.

Healthcare facilities (hospital pharmacies, home health providers, city care structures) that utilize any of these Cook Medical products must immediately check their inventory against the affected lot list. Any products matching the recalled lots should be quarantined and returned according to the procedures outlined in the Cook Medical notification letter. Facilities should confirm receipt of the direct notification from Cook Medical if they stock these products. Regulatory compliance teams should document recall acknowledgment and verify implementation of removal procedures.