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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Hemoflow Model 300-Applied Science, Inc

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.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002