Recall Z-2047-2016— Ceg Enterprises Llc

Name: FDA recall Z-2047-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-05

Class II · Terminated

Class II FDA medical device recall by Ceg Enterprises Llc, initiated 2016-04-05, terminated 2016-11-22. It names one FDA 510(k) clearance: K021258. 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.. Reason: 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..

Recalling firm: Ceg Enterprises Llc
Classification: Class II
Status: Terminated
Initiated: 2016-04-05
Terminated: 2016-11-22
Firm location: Hopkins, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K021258 — GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZERGerm Terminator Corporation·cleared 2002-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.