Gluma Desensitizer Power Gel Product Usage: Usage: This recall
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas…
Why was Gluma Desensitizer Power Gel Product Usage: Usage: This recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Heraeus Kulzer, LLC.
- 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,
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)