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Cook Inc. recalls Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction
Recalled March 2, 2016 · FDA recall Z-0865-2016 · Cook
Hazard
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. · FDA Class II
Units
25
Sold at
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Description
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →