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Recall of Level 1 H-31B Air Detector / Clamping Devices
Level 1 H-1200 Fast Flow Fluid Warmers

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    June 20, 2005


    Level 1 H-31B Air Detector / Clamping Devices
    Level 1 H-1200 Fast Flow Fluid Warmers (with integrated H-31B Air Detector/Clamp)

    (See attached list of affected Serial Numbers)


    Smiths Medical ASD, Inc.
    Rockland, MA


    Smiths Medical has received complaints for the Level 1 H-31B Air Detector/Clamping Device and Level 1 H-1200 Fast Flow Fluid Warmers with integrated H-31B Air Detector/Clamp. The Air Detector’s clamping mechanism may not close completely on the IV administration set and/or may have sensitive door/tubing secondary alarm interlocks. There is a possibility the fluid flow will not be stopped if air is detected, which could possibly lead to infusion of air into the patient. There is also a potential for a delay in therapy if the secondary alarm is overly sensitive.

    Consignees have been asked to contact the manufacturer to arrange for return of unit(s) for service.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


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