FDAFDA · Food and drugs·Recall number Z-1725-2013
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Published July 17, 2013 · Recall initiated: May 8, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The outer jacket is receding away from the black sensor prematurely.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SagaTech Electronics, Inc.
- Distributor
- Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
- Lot
- Model: 1.1 Lot numbers: 13367 and 13710
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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