Recall Z-1690-2017— Nonin Medical, Inc

Name: FDA recall Z-1690-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-29

Class II · Terminated

Class II FDA medical device recall by Nonin Medical, Inc, initiated 2016-09-29, terminated 2018-03-12. It names one FDA 510(k) clearance: K893221. Product: 8500M Handheld Pulse Oximeter. Reason: 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..

Recalling firm: Nonin Medical, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Terminated: 2018-03-12
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K893221 — MODEL 8500 HAND HELD PULSE OXIMETERNonin Medical, Inc.·cleared 1990-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.