Events

Recall of RemRest NonInvasive Continuous Positive Airway Pressure System, Model 903

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Industries America 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
    30085
  • Event Risk Class
    Class 2
  • Event Number
    Z-0326-05
  • Event Initiated Date
    2004-09-03
  • Event Date Posted
    2004-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35131
  • 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
    Ventilator, Non-Continuous (Respirator) - Product Code BZD
  • Reason
    Units could show an error code and stop functioning.
  • Action
    The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.

Device

RemRest NonInvasive Continuous Positive Airway Pressure System, Model 903
  • Model / Serial
    All serial numbers beginning with C0424
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.
  • Product Description
    RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
  • Manufacturer
    Medical Industries America Inc

Manufacturer

Medical Industries America Inc
  • Manufacturer Address
    Medical Industries America Inc, 2636 289th Pl, Adel IA 50003-8021
  • Source
    USFDA