Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
FDA device recall Z-0244-2016 · posted 2015-11-06 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KRA
- Quantity 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.
- Date initiated
- 2015-10-21
- Date posted
- 2015-11-06
- Date terminated
- 2016-11-28
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CXI SUPPORT CATHETER (K072724) | Cook, Inc. | 2007-11-09 |