FDA Device recall Z-0865-2016
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and… by Cook, citing incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0865-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-20 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | CA, FL, MI, NJ, NY, OH, OK, TX |
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
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Identifiers
| code_info | Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2016%22
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