Company: Baxter Healthcare Corp.
Date of Enforcement Report: 1/12/05
Class: II
PRODUCT
a) Colleague Single Channel Volumetric
Infusion Pumps, product code 2M8151
and 2M8151R; Made in Singapore; monochrome
display screen. Recall # Z-0342-05;
b) Colleague 3 Triple Channel Volumetric
Infusion Pumps, product code 2M8153
and 2M8153R; Made in Singapore; monochrome
display screen. Recall # Z-0343-05;
c) Colleague CX Single Channel Volumetric
Infusion Pumps, product code 2M8161
and 2M8161R; Made in Singapore; color
display screen. Recall # Z-0344-05;
d) Colleague 3 CX Triple Channel Volumetric
Infusion Pumps, product code 2M8163 and
2M8163R; Made in Singapore; color
display screen. Recall # Z-0345-05.
REASON
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated November 4, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
199,456 units.
DISTRIBUTION
Nationwide and Internationally.
