FDAFDA · Food and drugs·Recall number 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 non-tapered end catheters or diagnostic and interventional devices
Published March 2, 2016 · Recall initiated: January 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
- Lot
- Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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