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Heraeus Kulzer Recalls
2 recalls on record · March 12, 2014 to May 28, 2014 · Medical Devices
May 28, 2014Medical DevicesFDA
Heraeus Kulzer, LLC. recalls Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination o
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.
March 12, 2014Medical DevicesFDA
Heraeus Kulzer, LLC. recalls BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of
Hazard: As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C