BEUDAMED
    FDA Recall Terminated

    CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.

    Recall: Z-1013-2012 · Initiated February 17, 2011

    Recall

    Recall Number
    Z-1013-2012
    Event Number
    59094
    Firm
    Cardiopulmonary Instrumentation, Inc
    FEI Number
    1034275
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 17, 2011
    Posted
    February 14, 2012
    Terminated
    April 19, 2012
    Address
    3002 Nw 79th Ave, Doral, FL, 33122-1010

    Description

    CI healthcare***Model: CI8092***S/N: 5-60-85-044 MFD: JUN, 2010 MADE IN CHINA***cihealthcare.com This stainless steel stretcher is used for transporting patients.

    Reason

    Cardiopulmonary Instrumentation, Inc. dba CI Healthcare, Miami, FL, is recalling their Stainless Steel Patient Transport Stretcher, model # CI-8092, Lot 002, because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar, when secured in the first hook, to fall to a flat position.

    Action

    CI Healthcare sent an "URGENT RECALL NOTIFICATION" letter dated February 17, 2011, to its customer. The letter describes the product, problem and actions to be taken. The customer were instructed to do the following: 1) Examine their inventory and isolate the product(s). 2) If they have distributed any of the products to other services or facilities, please forward this information as appropriate. 3) Discontinue use of the product until a correction has been properly executed and 4) Complete and return the "Recall Response Form" as soon as possible. Should you have any questions, please call Robert Nunez at (305) 592-8196.

    Distribution

    Nationwide Distribution - to one distributor in Puerto Rico

    Quantity

    72 Units