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Heraeus Kulzer, LLC. recalls Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination o
Recalled May 28, 2014 · FDA recall Z-1651-2014 · Heraeus Kulzer
Hazard
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering. · FDA Class II
Units
5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Sold at
US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,
Description
The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.
Product
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
Manufacturer(s)
Heraeus Kulzer, LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →