FDA-Device2024-11-20Class II
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Hazard
Affected device lots have labels that state the incorrect expiration dates.
Sold states
Worldwide - US Nationwide distribution.
Affected count
5,953 US; 2,528 OUS
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2025More Cook Incorporated recalls
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