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DATE RECALL INITIATED: June 20, 2005 PRODUCTS / SERIAL NUMBERS: 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) MANUFACTURER: Smiths Medical ASD, Inc. Rockland, MA REASON: 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. 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.

Updated September 7, 2005

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