Reported May 28, 2014 · Terminated
Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of…
Heraeus Kulzer, LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heraeus Kulzer, LLC. · 300 Heraeus Dr · South Bend, IN · 46614-2557
Is this the product you have?
- Gluma
- Desensitizer Power Gel Product UsageUsage: 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
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Model Number(s): 66043451 Expiry: 2015-09 Syringe 2 Lot number 010103, which are contained within Kit 3 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. - Amount recalled
- 5,112 syringes or 1,278 kits (1 Kit=4 syringes)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Heraeus Kulzer, LLC. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.