Device product
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Z-0244-2016
Product summary
- Firm
- Cook Inc.
- Event
- Event 72518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-0244-2016
Official wording
Reason: 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.
Code information: Catalog number: CXI-2.6-18-90-P-NS-ANG Lot: 5505259 Expiration date: December 10, 2017 Catalog number: CXI-4.0-35-90-P-NS-0 Lots: 5505279 and 5505279X Expiration date: December 10, 2017
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.
Derived failure modes
-
Unknown
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.