Z-1725-2013 Class II Terminated
FDA device recall Z-1725-2013 was initiated by SagaTech Electronics, Inc. on May 8, 2008 and is designated Class II. Reason for recall: The outer jacket is receding away from the black sensor prematurely. The recall status is terminated (terminated July 22, 2013). Affected quantity: 152 units 77 devices from lot 13367 and 75 devices from lot 13710.
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2013
- Initiation Date
- May 8, 2008
- Termination Date
- July 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 152 units 77 devices from lot 13367 and 75 devices from lot 13710
Product Description
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Reason for Recall
The outer jacket is receding away from the black sensor prematurely.
Distribution Pattern
Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Code Information
Model: 1.1 Lot numbers: 13367 and 13710