Events

Recall of Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
    46947
  • Event Risk Class
    Class 2
  • Event Number
    Z-1379-2008
  • Event Initiated Date
    2008-03-04
  • Event Date Posted
    2008-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68610
  • 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
    Positive End Expiratory Pressure Attachment Breathing - Product Code BYE
  • Reason
    Incorrect oxygen level: device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. patient will not receive proper amounts of air/oxygen when in need.
  • Action
    Consignees were notified on 2/26/08 via telephone to place the affected products on hold pending further instruction from the recalling firm. A follow-up letter was issued on 3/4/08 advising consignees to return any product in stock for a replacement or credit. Distributors were requested to provide their customer lists to the recalling firm in order to notify their customers of this recall.

Device

Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System
  • Model / Serial
    Lot Numbers: 37L04D188 and 38A030257
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
  • Product Description
    Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA