Recall Z-0244-2016 ยท KRA Catheter, Continuous Flush
Cook Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
| Date | Nov 6, 2015 (initiated Oct 21, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Cook Medical sent an Urgent: Medical Device Recall letter dated October 20, 2015, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, customer responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072724 | CXI SUPPORT CATHETER Cook, Inc., Nov 9, 2007 |