BEUDAMED
    FDA Recall Terminated

    PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.

    Recall: Z-1561-2010 · Initiated March 5, 2010

    Recall

    Recall Number
    Z-1561-2010
    Event Number
    55117
    Firm
    Precision Medical, Inc.
    FEI Number
    2523148
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 5, 2010
    Posted
    May 9, 2010
    Terminated
    December 13, 2010
    Address
    300 Held Dr, Northampton, PA, 18067-1150

    Description

    PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.

    Reason

    The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"

    Action

    The recalling firm issued Customer Alert Product Recall letters on 3/5/10 to inform users of the problem and how to identify affected product.

    Distribution

    The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada

    Quantity

    19,518