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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Medical Device Removal – AXP Processing Bagset-ThermoGenesis

Updated: Additional lot numbers
DATE NOTIFICATION INITIATED:

October 24, 2008
November 13, 2008

PRODUCT / LOT NUMBER:

AXP Processing Bagset
Model 8-5101
Lot Numbers: 08A29, 08B13, 08B20, 08B25, 08C04, and 08C11

MANUFACTURER:

Thermogenesis Corporation
Rancho Cordova, CA

REASON:

ThermoGenesis has determined that there is a potentially serious issue associated with the use of these lots. They have become aware that particulates from the stopcock in the bagset may be released into the sterile, non-pyrogenic fluid path. While all materials used in the bagsets are biocompatible, the introduction of any particulate into the body could result in serious injury to a patient being transfused with cord blood that has been stored in these units.

 

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