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Cook Inc. Recall: Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-

Cook Inc. Recall: Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0- is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cook Inc.; Product: Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, c

Recalling firmCook Inc.
ProductFlexor 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
Reason for recallIncorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Recall initiated20160120
Recall numberZ-0865-2016
Categorydevice
StateIN
CountryUnited States

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