FDA-Device2015-11-18Class II
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Cook Inc.
Hazard
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.
Sold states
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.
Affected count
38
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0244-2016Don't want to check this manually?
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