Baxter International has received FDA's final order regarding the previously communicated recall of Colleague infusion pumps from the US market. The company expects to offer replacement infusion pumps or refunds to owners of Colleague pumps and also expects to execute the recall over the next two years to minimise disruption to patient care.
The replacement option permits customers to exchange Colleague infusion pumps for Sigma Spectrum next-generation smart pumps. Alternatively, Colleague pump owners may receive the lesser of the pump’s depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, or the purchase price.
According to Baxter, customers who did not purchase their pumps directly from the company, must provide proof of purchase to verify the purchase price in order to qualify for a refund. Baxter will also permit US pump lessees to terminate their leases without penalty upon the return of the devices.
Baxter said that during the 24-month transition period, customers may continue to use Colleague infusion pumps and receive service and support provided that a certificate of medical necessity form has been completed. The company expects to provide a transition guide to help customers in replacing Colleague infusion pumps.
Outside the US, Baxter has continued to update the Colleague device and will be initiating an additional program to provide customers with enhanced Colleague devices that 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.
Peter Arduini, president of medication delivery business of Baxter, said: “Baxter’s goal is to support a seamless transition by providing choices that best address the needs of our hospital customers and minimize disruption to the delivery of patient care. We are continuing to work with Sigma to increase production capacity of the Spectrum pump in order to meet the anticipated demand for this device.
“Our actions in the US as well as our planned Colleague exchange program outside the US are intended to demonstrate our commitment to customers and patients around the world.”