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.
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
