BEUDAMED
    FDA Recall 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 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-1653-2013
    Event Number
    65286
    Firm
    Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom
    FEI Number
    3002807907
    Product Code
    CAD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 14, 2013
    Posted
    July 2, 2013
    Terminated
    May 12, 2014

    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.

    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.

    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)