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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65148
Product Type Devices
Status Completed
Recalling Firm SagaTech Electronics, Inc.
City Calgary
State AB
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-05-08
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution:US (nationwide) and countries of:Canada and Mexico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study. Model: 1.1 Lot numbers: 13367 and 13710 Class II The outer jacket is receding away from the black sensor prematurely. 152 units 77 devices from lot 13367 and 75 devices from lot 13710 Z-1725-2013
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