Cook Inc.: Medical Device Recall in 2015 - (Recall #: Z-0244-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 21, 2015

Date Posted: November 18, 2015

Recall Number: Z-0244-2016

Event ID: 72518

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.

Status: Terminated

Product Quantity: 38

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated