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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448