Company: Baxter Healthcare Corporation,
Date of Enforcement Report: 7/27/05
Class: I
PRODUCT
a) Baxter Colleague Single Channel Volumetric
Infusion Pumps, product codes: 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05;
b) Baxter Colleague triple Channel Volumetric
Infusion Pumps, product codes: 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05
REASON
The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL, by letter on March 15, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
253,185 pumps
DISTRIBUTION
Nationwide and Internationally
