FDAClass IIMarch 2, 2016

Flexor Check-Flo Introducer recall

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered…

Why was Flexor Check-Flo Introducer recalled?

Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

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…
Recalling firm
Cook Inc.
Quantity
25
Distribution
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls