Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0244-2016 — Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

U.S. FDA — Device Enforcement · United States · 2015-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0244-2016
Date of alert
2015-10-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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