Home / Recalls / Medical Devices
Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product i
Recalled October 4, 2017 · FDA recall Z-3215-2017 · Ultradent Products
Hazard
The barcode label was placed underneath the sterile barrier and the product was re-wrapped. · FDA Class II
Units
95 units
Sold at
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Description
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Product
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 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.
Manufacturer(s)
Ultradent Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →