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.