BEUDAMED
    FDA Recall Terminated

    Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks.

    Recall: Z-0969-2007 · Initiated November 24, 2006

    Recall

    Recall Number
    Z-0969-2007
    Event Number
    36955
    Firm
    Fisher & Paykel Healthcare Inc
    FEI Number
    3000210616
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 24, 2006
    Posted
    June 27, 2007
    Terminated
    March 26, 2012
    Address
    15365 Barranca Parkway, Irvine, CA, 92618

    Description

    Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks.

    Reason

    Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not featu

    Action

    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.

    Distribution

    Nationwide

    Quantity

    815,239 total for all models, all lots