Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Reported: November 18, 2015 Initiated: October 21, 2015 #Z-0244-2016
Product Description
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.. Recalled by Cook Inc.. Units affected: 38.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0244-2016.
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