Events

Recall of Device Recall Penlon Sigma Delta Vaporizer

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

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
    65286
  • Event Risk Class
    Class 2
  • Event Number
    Z-1653-2013
  • Event Initiated Date
    2013-05-14
  • Event Date Posted
    2013-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118458
  • 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
    Vaporizer, anesthesia, non-heated - Product Code CAD
  • Reason
    It has come to penlon ltd's attention of an instance where the installation and pre-use checks listed in the user manual may not have been followed prior to the clinical use of the vaporizer. penlon ltd has updated the installation and daily pre-use check sections of the user manual to ensure that the instructions are explicit and clear.
  • Action
    Penlon sent an Urgent Field Safety Notice dated May 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded and requested to follow the instructions for daily pre-use checks, initial checks, and servicing. Customers were instructed to distribute the notice to all personnel who need to be aware within their organization and to any organization where the devices are used. For questions regarding this recall call 01235 547000.

Device

Device Recall Penlon Sigma Delta Vaporizer
  • Model / Serial
    All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
  • Product Description
    Delta Vaporizer || An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
  • Manufacturer
    Penlon, Ltd.

Manufacturer

Penlon, Ltd.
  • Manufacturer Address
    Penlon, Ltd., Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • Manufacturer Parent Company (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA