BEUDAMED
    FDA Recall Terminated

    Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD

    Recall: Z-0444-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0444-2007
    Event Number
    36306
    Firm
    Puritan Bennett Corporation
    FEI Number
    2024500
    Product Code
    MNT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2006
    Posted
    January 9, 2007
    Terminated
    March 5, 2014
    Address
    5931 Priestly Dr, Ste 100, Carlsbad, CA, 92008-8813

    Description

    Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD

    Reason

    Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.

    Action

    Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.

    Distribution

    Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.

    Quantity

    7,754 (in US)