Reported Nov 18, 2015 · Terminated
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
- Lot codes and dates
- Catalog numberCXI-2.6-18-90-P-NS-ANG
- Lot5505259
- Expiration date
December 102017
- Catalog numberCXI-4.0-35-90-P-NS-0
- Lots5505279
- and 5505279X Expiration date
December 102017
- Amount recalled
- 38
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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