FDAFDA · Food and drugs·Recall number Z-1740-2014
bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
Published June 18, 2014 · Recall initiated: April 14, 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
A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ivoclar Vivadent, Inc.
- Distributor
- Worldwide Distribution: US Nationwide and the country of Canada.
- Lot
- Reference number 636241, all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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