Company:Baxter Healthcare Corp
Date of Enforcement Report:7/25/2007
Class:l
PRODUCT
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007
REASON
A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 20-21, 2007 and by letters dated June 22, 2007.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4,512 pumps
DISTRIBUTION
Nationwide and Internationally
