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DATE RECALL INITIATED: June 14, 2005 PRODUCT: Hemoflow Model 300 Product Code 9-3000-0xxx Serial Numbers: B4162 thru B4167; B4225 thru B4314, and B4315 thru B4324 MANUFACTURER: Applied Science, Inc Grass Valley, CA REASON: Hemoflow Model 300 mixer may fail to start at the beginning of a draw due to a mismatch between motor characteristics and driver circuitry. The event will trigger a "Job Error" requiring the draw to be completed manually using the SCALE mode while manually mixing the blood and anticoagulant. Consignees have been asked to contact the manufacturer to arrange for device correction. 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 July 14, 2005

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