Recall Z-0865-2016— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2016-01-20, terminated 2016-11-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-20
- Terminated
- 2016-11-21
- Firm location
- Bloomington, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.