Cook Medical CXI Support Catheter 2 — Class II medical device recall Z-0244-2016
Terminated recall by Cook Inc., reported 2015-11-18, distributed in CA, FL, ID, IL, MA, NY, OK, TX…. Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mi
| Recall number | Z-0244-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-11-28 |
| Distributed | CA, FL, ID, IL, MA, NY, OK, TX, UT, VA |
| Countries outside the US | AT, CA, DE, ES, FR, GB, HU, SE |
| Quantity | 38 |
| Lot numbers | 5505259, 5505279, 5505279X |
| Model numbers | 5505279, 5505279X, 90-P-NS-ANG, CXI-4.0-35-90-P-NS-0 |
| Expiration dates | 2017-12-10 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0244-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.