Events

Recall of Device Recall Infant Flowsensor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hamilton 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
    71434
  • Event Risk Class
    Class 2
  • Event Number
    Z-1964-2015
  • Event Initiated Date
    2015-06-01
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137749
  • 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
    Set, tubing and support, ventilator (w harness) - Product Code BZO
  • Reason
    An issue has been discovered with the hamilton medical infant flow sensor, single use. when a ventilation mode with adaptive volume control (apvcmv/cmv+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
  • Action
    Hamilton Medical Inc sent a Medical Device Safety Notices letter dated May 8, 2015 by traceable method to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Technical Support Manager at 800-426-6331, Ext 215.

Device

Device Recall Infant Flowsensor
  • Model / Serial
    PN 155500, all lot codes.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. || Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
  • Manufacturer
    Hamilton Medical, Inc.

Manufacturer

Hamilton Medical, Inc.
  • Manufacturer Address
    Hamilton Medical, Inc., 4990 Energy Way, Reno NV 89502-4123
  • Manufacturer Parent Company (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA