Company:Baxter Healthcare, Corp
Date of Enforcement Report 11/17/10//2010
Class l:

PRODUCT
) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z-0001-2011;

2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes:
2M 8153 and 2M 8163. Recall # Z-0002-2011;

REASON
The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated August 4, 2010.
Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
302,872 pumps

DISTRIBUTION
Nationwide