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Terminated

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

FDA Recall Z-0244-2016 · Posted 2015-11-06

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2015-10-21
Date Terminated2016-11-28
Product Quantity38

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.

Firm 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.

Root Cause

Labeling mix-ups

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072724CXI SUPPORT CATHETERCook, Inc. · 2007-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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