Z-0865-2016Class II

Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for...

Name: Z-0865-2016 Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for...
Creator: Cook Inc.
Published: 2016-01-20
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-01-20 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of 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... on 2016-01-20. FDA classified it as Class II and gives the reason as "Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0865-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-20
Posted: 2016-02-24
Terminated: 2016-11-21
Recalling firm: Cook Incorporated
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
Product code: DYB Introducer, Catheter
Reason for recall: Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
Quantity in commerce: 25
Distribution: Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Product codes and lots: Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0865-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-24

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)