Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pai

FDA device recall Z-1651-2014 · posted 2014-05-23 · Terminated

Recall details

Recalling firm

Heraeus Kulzer, LLC.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LBH

Quantity affected

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,

Date initiated

2014-04-23

Date posted

2014-05-23

Date terminated

2014-11-05

Location

South Bend, IN