FDA-Device2024-11-27Class II
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Hazard
Devices from the affected device lots have labels that state the incorrect expiration dates.
Sold states
International Distribution to: Korea only
Affected count
10 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2025More Cook Incorporated recalls
- FDA-Device2026-04-15Cook Medical arterial pressure monitoring trays recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
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