Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0156-2007

DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home...

Lumiport, LLC / initiated 2006-09-28 / Terminated

Lumiport, LLC began a recall of DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC on . The reason FDA records is "Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0156-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lumiport, LLC
Product
DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.
Product code
MOQ Battery, Replacement, Rechargeable
Reason for recall
Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.
FDA root cause
Other
Action
Individual customers were contacted through e-mail and/or telephone beginning 09/28/2006. They were told to stop charging and using their current DermaStyle and to destroy it to prevent accidental usage. New replacements will be mailed to all customers.
Quantity in commerce
2480 units
Distribution
World wide Distribution-sales by direct mail or internet-USA and Canada
Product codes and lots
All units sold before 08/01/2006.