Z-0244-2016 Class II Terminated
FDA device recall Z-0244-2016 was initiated by Cook Inc. on Oct 21, 2015 and is designated Class II. 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… The recall status is terminated (terminated Nov 28, 2016). Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 18, 2015
- Initiation Date
- Oct 21, 2015
- Termination Date
- Nov 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
Product Description
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
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.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0244-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026