Flexor Check-Flo Introducer — Class II medical device recall Z-0865-2016
Terminated recall by Cook Inc., reported 2016-03-02, distributed in CA, FL, MI, NJ, NY, OH, OK, TX. Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
| Recall number | Z-0865-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2016-01-20 |
| Classified | 2016-02-24 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-11-21 |
| Distributed | CA, FL, MI, NJ, NY, OH, OK, TX |
| Quantity | 25 |
| Reason classes | labeling |
| Lot numbers | 6166304 |
| Model numbers | KCFW-6.0-35-70-RB-HFANL0-HC |
Product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Reason for recall
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
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-0865-2016. 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.