BEUDAMED
    FDA Recall Terminated

    Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.

    Recall: Z-1068-05 · Initiated March 25, 2005

    Recall

    Recall Number
    Z-1068-05
    Event Number
    31611
    Firm
    Chad Therapeutics Inc
    FEI Number
    2024040
    Product Code
    BZD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2005
    Posted
    August 3, 2005
    Terminated
    August 30, 2006
    Address
    21622 Plummer St, Chatsworth, CA, 91311-4106

    Description

    Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***.

    Reason

    "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse.

    Action

    Firm recalled via email and letter on 3/25/2005. Firm is requesting returns of all units. Recall is on-going and is to the user or patient level.

    Distribution

    Nationwide and to Canada, Sweden, Norway***

    Quantity

    ***244 units***