—#141357

Product

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

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K072724
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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.

Timeline

Recall initiated: 2015-10-21
Posted by FDA: 2015-11-06
Terminated: 2016-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.