Events

Recall of Device Recall Nasal Cannula Diagnostic Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventus 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
    54668
  • Event Risk Class
    Class 3
  • Event Number
    Z-2435-2010
  • Event Initiated Date
    2009-12-03
  • Event Date Posted
    2010-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88965
  • 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
    Ventilatory Effort Recorder - Product Code MNR
  • Reason
    The catalog number printed on two nasal cannula diagnostic kits (mrs0231) was different that the catalog number printed on the bulk pack shipper box and the other nasal cannula kits in the same shipper (mrs0208). no devices were used on any patient .
  • Action
    Ventus Medical, Inc. of Belmont, CA has notified all customers who received distribution from the affected manufacturing lot (1880783) to immediately return the product in question for replacement. If there are any questions regarding this correction, please contact the firm at (650) 632-4165.

Device

Device Recall Nasal Cannula Diagnostic Kit
  • Model / Serial
    Catalog Number: MRS0208 Lot Number: 1880783
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed in the US through a single distribution supplier.
  • Product Description
    The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
  • Manufacturer
    Ventus Medical, Inc.

Manufacturer

Ventus Medical, Inc.
  • Manufacturer Address
    Ventus Medical, Inc., 1301 Shoreway Rd Ste 340, Belmont CA 94002-4155
  • Manufacturer Parent Company (2017)
    Ventus Medical Inc.
  • Source
    USFDA