COLLEAGUE Transition Information Center
On July 13, 2010, Baxter announced final details regarding the recall of COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing consent decree with the U.S. Food and Drug Administration (FDA). Baxter will offer replacement infusion pumps or refunds to owners of COLLEAGUE pumps in the U.S. and will execute the recall over the next 24 months. Details include:
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The replacement option permits customers who purchased their COLLEAGUE pumps from Baxter to exchange them for Sigma SPECTRUM second-generation smart infusion pumps;
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Alternatively, COLLEAGUE pump owners may receive a refund for the lesser of the pump's value-which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump-or the purchase price.
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Baxter will also permit U.S. pump lessees to terminate their leases without penalty upon the return of the devices.
To participate in the replacement and refund program, U.S. customers will need to fill out a Certificate of Medical Necessity. In addition, Baxter has created a Transition Guide to further assist customers throughout the 24-month transition period.
Baxter's goal during this process will be to support a seamless transition by providing choices that best address the needs of customers and minimize disruption to the delivery of patient care. It is also important to note that no new safety issues have been identified with COLLEAGUE and the device may continue to be used safely throughout this transition if used in accordance with the operator's manual, as well as additional instructions contained in customer letters.
This site was created to provide the latest information about the recall. Please check back for updates on a regular basis. To contact Baxter, click here.
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September 2010: COLLEAGUE Transition Guide Now Available
