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Ultradent Products, Inc. recalls Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. T
Recalled June 27, 2012 · FDA recall Z-1822-2012 · Ultradent Products
Hazard
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. · FDA Class II
Units
172 kits (4 syringes per kit)
Sold at
Worldwide Distribution.
Description
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
Product
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Manufacturer(s)
Ultradent Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →