Z-0865-2016 Class II Terminated
FDA device recall Z-0865-2016 was initiated by Cook Inc. on Jan 20, 2016 and is designated Class II. Reason for recall: Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. The recall status is terminated (terminated Nov 21, 2016). Affected quantity: 25.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Jan 20, 2016
- Termination Date
- Nov 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
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.
Distribution Pattern
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
Code Information
Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0865-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026