8500M Handheld Pulse Oximeter recall
8500M Handheld Pulse Oximeter
Why was 8500M Handheld Pulse Oximeter 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.
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?
502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090
- Product
- 8500M Handheld Pulse Oximeter
- Recalling firm
- Nonin Medical, Inc
- Quantity
- 15 (11 US; 4 OUS)
- Distribution
- Distribution in US (MI, NC, OH, NC, VA), and CANADA
- Recall date
- April 5, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)