Recall Z-1651-2014 ยท LBH Varnish, Cavity
Heraeus Kulzer, LLC.
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.
| Date | May 23, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Heraeus Kulzer sent a Voluntary Recall letter dated April 22, 2014 to all affected doctors and supply centers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Inspect your inventory, both in storage and in use, and identify the lot number on your kits and syringes. Refer to attached images. 2. If you identify any Gluma Desensitizer PowerGel with the aforementioned kit or syringe lot numbers, immediately cease usage of this product and call Technical Services at 1 (574) 299-5409 3. Please advise if you forwarded this product |
| Quantity | 5,112 syringes or 1,278 kits (1 Kit=4 syringes) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.