Reported Apr 5, 2017 · Terminated
8500M Handheld Pulse Oximeter
Nonin Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nonin Medical, Inc · 13700 1st Ave N · Plymouth, MN · 55441-4595
Is this the product you have?
- 8500M Handheld Pulse Oximeter
- Lot codes and dates
502002091502002088502002087502002083502002085502002086502002081502002082502002080502002079502002077502002078502002089502002090
- Amount recalled
- 15 (11 US; 4 OUS)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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