FDAFDA · Food and drugs·Recall number Z-3214-2017
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Published October 4, 2017 · Recall initiated: August 4, 2017
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 barcode label was placed underneath the sterile barrier and the product was re-wrapped.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultradent Products, Inc.
- Distributor
- Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
- Lot
- Lot numbers BCDZQ, BCPRC, and BD3MT
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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