BEUDAMED
    FDA Recall Terminated

    RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.

    Recall: Z-0326-05 · Initiated September 3, 2004

    Recall

    Recall Number
    Z-0326-05
    Event Number
    30085
    Firm
    Medical Industries America Inc
    FEI Number
    1931654
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2004
    Posted
    December 17, 2004
    Terminated
    August 18, 2005
    Address
    2636 289th Pl, Adel, IA, 50003-8021

    Description

    RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.

    Reason

    Units could show an error code and stop functioning.

    Action

    The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.

    Distribution

    Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.

    Quantity

    74 units