FDAClass IIJuly 17, 2013

Finger Sensor for Remmers Recorder recall

Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.

Why was Finger Sensor for Remmers Recorder recalled?

The outer jacket is receding away from the black sensor prematurely.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: 1.1 Lot numbers: 13367 and 13710

Product
Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Recalling firm
SagaTech Electronics, Inc.
Quantity
152 units 77 devices from lot 13367 and 75 devices from lot 13710
Distribution
Worldwide Distribution: US (nationwide)¿and countries of: ¿Canada and Mexico.
Recall date
July 17, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls