Z-1690-2017 Class II Terminated

Recalled by Nonin Medical, Inc — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
April 5, 2017
Initiation Date
September 29, 2016
Termination Date
March 12, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 (11 US; 4 OUS)

Product Description

8500M Handheld Pulse Oximeter

Reason for Recall

Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.

Distribution Pattern

Distribution in US (MI, NC, OH, NC, VA), and CANADA

Code Information

502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090