FDA-Device2016-03-02Class II
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
Cook Inc.
Hazard
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Sold states
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Affected count
25
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2016Don't want to check this manually?
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