Events

Recall of Device Recall DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder

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-0731-2007
  • 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=50073
  • 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 PD1000A Pulse Dose Oxygen Conserving Cylinder
  • Model / Serial
    Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055; Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328; Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922; Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191; Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132; and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-original shipments to distributors/dealers USA and Canada.
  • Product Description
    DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
  • Manufacturer
    Sunrise Medical

Manufacturer

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