Urgent Medical Device Removal
AXP Processing Bagset
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.
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.