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
Reported: March 2, 2016 Initiated: January 20, 2016 #Z-0865-2016
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 25
- Distribution
- Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cook Inc.. Units affected: 25.
Why was this product recalled? ▼
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0865-2016.
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