FDAFDA · Food and drugs·Recall number Z-0139-2015
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Published November 5, 2014 · Recall initiated: October 19, 2014
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
The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biosense Webster, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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