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Gluma Desensitizer Powergel (2014-04-23)
- Starting date:
- April 23, 2014
- Posting date:
- June 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39811
Recalled Products
Gluma Desensitizer Powergel
Reason
The 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 and patient or user face or eyes
Affected products
Gluma Desensitizer Powergel
Lot or serial number
Not applicable
Model or catalog number
66043451
Companies
- Manufacturer
-
Heraeus Kulzer GmbH
Gruner Weg 11
Hanau,Germany
63450