FDA recall Z-0347-2025

Cook Incorporated · Class II · device

Product

Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST

Reason for recall

Affected device lots have labels that state the incorrect expiration dates.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-10-08
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2025