Cook Medical CXI Support Catheter 2.6FR curved catheter recall
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Why was Cook Medical CXI Support Catheter 2.6FR curved catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
- Recalling firm
- Cook Inc.
- 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.
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)