Events

Recall of Device Recall DeVilbiss 535DX CF Continuous Flow Cylinder (Oxygen)

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

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
    37189
  • Event Risk Class
    Class 2
  • Event Number
    Z-0732-2007
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2007-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50656
  • 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
    Oxygen cylinders - Product Code NFB
  • Reason
    Cylinder could lose oxygen at high pressure after the filling process.
  • Action
    The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.

Device

Device Recall DeVilbiss 535DX CF Continuous Flow Cylinder (Oxygen)
  • Model / Serial
    Model 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-original shipments to distributors/dealers USA and Canada.
  • Product Description
    535D-X CF Continuous Flow Cylinder
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical
  • Manufacturer Address
    Sunrise Medical, 100 Devilbiss Dr, Somerset PA 15501-2125
  • Source
    USFDA