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U.S. Department of Health and Human Services

Class 2 Device Recall Gluma Desensitizer Power Gel

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 Class 2 Recall
Gluma Desensitizer Power Gel
see related information
Date Posted May 23, 2014
Recall Status1 Open
Recall Number Z-1651-2014
Recall Event ID 68223
Premarket Notification
510(K) Number
K093575 
Product Classification Varnish, Cavity - Product Code LBH
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.
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.
Recalling Firm/
Manufacturer
Heraeus Kulzer, LLC.
300 Heraeus Dr
South Bend, Indiana 46614-2557
For Additional Information Contact Audi Bogucki
800-431-1785
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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 to any other end users. We will need their contact information inClusive of name, address and phone number. For questions regarding this notification, please call our Technical Service team at (574) 299-5409.
Quantity in Commerce 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,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LBH and Original Applicant = HERAEUS KULZER, LLC
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