COLLEAGUE Information for Customers Outside of the United States
Intended for Healthcare Professionals Outside the U.S.
Baxter is planning for the next COLLEAGUE product release which will provide customers outside of the U.S. with newly manufactured pumps, at no cost.
Based on the company's continuous improvement efforts, the next release of COLLEAGUE has been developed through a holistic approach to addressing the pump's design. It will address all of the items described in our open recall notification (communicated in January 2009) and will contain a new battery management system, as well as further upgrades to software and mechanical systems to improve the product's user interface and performance.
Having completed rigorous testing to confirm that the pump performs as expected, Baxter initiated regulatory filings for this pump update in July 2010. Following regulatory approval -and once Baxter is confident that the company's full-range of support structures is sufficiently in place-the company will initiate its planned deployment process.
Deployment will take the form of an exchange program wherein each of a facility's existing COLLEAGUE pumps will be replaced with newly manufactured COLLEAGUE pumps, at no cost. This free exchange will take place regardless of the depreciated value of the COLLEAGUE pumps within the facility.
Country-by-country deployment plans are currently being addressed. Please be advised until such time as the deployment plan is implemented, existing COLLEAGUE pumps continue to be safe when used in accordance with the Operator's Manual and additional instructions provided to you in prior notifications.
Baxter is committed to executing a deployment process that is expeditious, equitable and seamless for all COLLEAGUE customers around the world. The company will continue to provide updates with additional relevant information. If customers have questions in the meantime, they may click here to contact Baxter, or contact their local Baxter representative.
