FDAClass IIAugust 5, 2015

OxiMax N-65 Handheld Pulse Oximeter. N65 recall

OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation…

Why was OxiMax N-65 Handheld Pulse Oximeter. N65 recalled?

Potential missing segments on the display that can result in misinterpretation of data.

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?

All Lots of Product Code N650, N65, N65-1, N65P, N65P-1

Product
OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation…
Recalling firm
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Quantity
211,426 units
Distribution
Worldwide Distribution - US Nationwide including Canada.
Recall date
August 5, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls