Z-1651-2014 Class II Terminated
FDA device recall Z-1651-2014 was initiated by Heraeus Kulzer, LLC. on April 23, 2014 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated November 5, 2014). Affected quantity: 5,112 syringes or 1,278 kits (1 Kit=4 syringes).
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- April 23, 2014
- Termination Date
- November 5, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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,
Code Information
Model Number(s): 66043451 Expiry: 2015-09 Syringe Lot number 010103, which are contained within Kit lot numbers 42.43.44.45.46.47.48.49,50, and 51. Note; lots 49 and 50 were captured in house, 0 was distributed. Lot 51 was made by the manufacturer, however, never received by us or distributed.