Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2047-2016Class II

Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam...

Ceg Enterprises LLC / initiated 2016-04-05 / Terminated / root cause: labeling and UDI

Ceg Enterprises Llc began a recall of Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two... on . FDA classified it as Class II and gives the reason as "CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2047-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Ceg Enterprises LLC
Product
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
Product code
MCF Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Reason for recall
CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.
Root cause tag
labeling and UDI
FDA root cause
Unknown/Undetermined by firm
Action
CEG Enterprises sent an Urgent Germ Terminator Toothbrush Sanitizer GT100 Recall letter dated April 19, 2016, via UPS and email to all affected customers. The letter identified the affected product, the reason for recall, stated to quarantine product, and to return all remaining product. The letter also instructed that Tuesday Morning retail stores post the recall notification letter on the retail shelves where the product was offered for sale, as well as on their website. Consumers are encouraged to return the device to a Tuesday Morning retail store. Questions can be directed to 612-337-1821
Quantity in commerce
100,548 units
Distribution
Nationwide Distribution through Tuesday Morning retail stores.
Product codes and lots
Model GT100

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2047-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2047-2016Class IITerminatedVoluntary: Firm initiated