BEUDAMED
    FDA Recall Terminated

    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111

    Recall: Z-0695-06 · Initiated December 20, 2005

    Recall

    Recall Number
    Z-0695-06
    Event Number
    34248
    Firm
    Fisher & Paykel Healthcare Inc
    FEI Number
    3000210616
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2005
    Posted
    March 29, 2006
    Terminated
    April 19, 2012
    Address
    22982 Alcalde Drive, 101, Laguna Hills, CA, 92653

    Description

    Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111

    Reason

    Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.

    Action

    On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.

    Distribution

    Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution

    Quantity

    260 boxes (2,600 pcs)