Events

Recall of Nonin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nonin Medical, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75424
  • Event Risk Class
    Class 2
  • Event Number
    Z-1690-2017
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150238
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Oximeter - Product Code DQA
  • 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.
  • Action
    Consignees were called and sent on 9-29-2016 a Nonin Urgent Medical Device Recal" letter dated 29 September, 2016. The letter described the problem and the product involved in the recall. Additionally, it described the Potential Risk and Required Action. Requested consignees to return the affected units and to forward the contact information if the unit is no longer in their inventory. For questions contact Kim.Aves@nonin.com or via direct telephone at 763 577 3196.

Device

Nonin
  • Model / Serial
    502002091  502002088  502002087  502002083  502002085  502002086 502002081  502002082  502002080  502002079  502002077  502002078  502002089 502002090
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution in US (MI, NC, OH, NC, VA), and CANADA
  • Product Description
    8500M Handheld Pulse Oximeter
  • Manufacturer
    Nonin Medical, Inc

Manufacturer

Nonin Medical, Inc
  • Manufacturer Address
    Nonin Medical, Inc, 13700 1st Ave N, Plymouth MN 55441-4595
  • Manufacturer Parent Company (2017)
    Nonin Medical, Inc.
  • Source
    USFDA