BEUDAMED
    FDA Recall Terminated

    Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.

    Recall: Z-0568-2010 · Initiated October 29, 2008

    Recall

    Recall Number
    Z-0568-2010
    Event Number
    53339
    Firm
    Paramed Systems
    FEI Number
    3004828791
    Product Code
    FPP
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    October 29, 2008
    Posted
    December 28, 2009
    Terminated
    January 28, 2010
    Address
    8100 S 1300 W, Ste D, West Jordan, UT, 84088-8307

    Description

    Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.

    Reason

    Possible partial board disassembly due to inadequate webbing attachment.

    Action

    Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices.

    Distribution

    Nationwide Distribution -- Including states of AZ, CA, FL, GA, IL, IN, KS, KY, MA, MI, MT, NY, PA, SC, TN and UT.

    Quantity

    722 Units