Humidifiers, Heated Humidifiers, Pass-over Humidifiers, Cold Humidifiers,
Passive Humidiers for Sleep Apnea, CPAP Equipment, CPAP Supplies from Fisher
& Paykel, HumidAire, Respironics, ResMed (Sullivan), DeVilbiss, Hudson,
ConchaTherm, Puritan Bennett, and The CPAP StoreRespironics, the manufacturer of the Respironics REMstar® Heated Humidifier, has received complaints of failures of the AC inlet connector on the REMstar Heated Humidifiers manufactured between December 2001 and April 2003. A small number of these failures have resulted in thermal damage to the humidifier enclosure, and there is a remote possibility that a thermal failure could result in the ignition of materials external to the device. For this reason, Respironics is asking that you remove the humidifier from its power source. You may continue using your CPAP device.
Respironics has decided to take voluntary action to mitigate the risk of failure. This action includes only the model 1005792, U1005792, R1005792, SC1005792, AC1005792, and 1007861.
This voluntary action is classified as a medical device recall, and is being conducted with the knowledge of the United States Food and Drug Administration (FDA).
WHAT TO DO:
If you did not purchase your
Respironics REMstar® Heated Humidifier from The CPAP Store LLC, call Stericycle, Inc at 877-574-5038 or
317-275-7667.
If you purchased your Respironics REMstar® Heated Humidifier from The CPAP Store LLC between December 2001 and April 2003, call us immediately at 877-272-7626 or 509-735-1842. You can also email us at any of the following email addresses: joe@cpapman.com; orders@cpapman.com or accounting@cpapman.com.
WHAT YOU WILL NEED:
You will need the serial number of your Respironics REMstar® Heated
Humidifier. It is located on the bottom of the unit.
WHAT THE CPAP STORE LLC WILL DO:
The CPAP Store LLC will ship you a replacement machine at no cost.
YOUR RESPONSIBILITY:
You will be responsible for packing and shipping your recalled unit back
to Respironics. A prepaid, self-addressed label is included with the replacement
machine. You will use the packaging that your recall replacement machine
comes in to send your recalled machine back with.
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