BEUDAMED
    FDA Enforcement Class II Terminated

    Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

    Recall: Z-1653-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1653-2013
    Event ID
    65286
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Penlon, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    May 14, 2013
    Classification Date
    July 2, 2013
    Termination Date
    May 12, 2014
    Address
    Abingdon Science Park, Barton Lane, Abingdon, N/A, N/A, United Kingdom

    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.

    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.

    Code Info

    All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.

    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.

    Quantity

    9208 (of which 576 were within the US)