FDA-Device2024-11-20Class II
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Cook Incorporated
Hazard
Affected device lots have labels that state the incorrect expiration dates.
Sold states
Worldwide - US Nationwide distribution.
Affected count
2,005 US; 1,145 OUS
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0346-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief