Z-0244-2016Class II

Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use

Name: Z-0244-2016 Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use
Creator: Cook Inc.
Published: 2015-10-21
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2015-10-21 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use on 2015-10-21. FDA classified it as Class II and gives the reason as "Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during...". 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-0244-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Posted: 2015-11-06
Terminated: 2016-11-28
Recalling firm: Cook Incorporated
Product: Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Cook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, customer 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 1-800-457-4500 or 1-812-339-2235.
Quantity in commerce: 38
Distribution: Worldwide Distribution - US Distribution to the states of : CA, FL, ID, IL, MA, NY, OK, TX, UT and VA., and to the countries of Canada, Austria, Germany, Spain, France, Hungary, Sweden and UK.
Product codes and lots: Catalog number: CXI-2.6-18-90-P-NS-ANG Lot: 5505259 Expiration date: December 10, 2017 Catalog number: CXI-4.0-35-90-P-NS-0 Lots: 5505279 and 5505279X Expiration date: December 10, 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0244-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0244-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code KRA

K072724Class IICxi Support CatheterCook, Inc. / cleared 2007-11-09

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)