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Baxter receives final FDA order for Colleague recall

This article was originally published in Clinica

Executive Summary

The recall of Baxter International's Colleague infusion pumps in the US is to take place over the next two years. Baxter was prompted to reveal the full details of its recall plan for the products after the US FDA issued its final order concerning the action. Owners of the faulty pump may exchange the product for Baxter’s Sigma Spectrum pump, or they could receive either the pump’s depreciated value, which is no less than $1,500 for a single-channel pump or $3,000 for a triple-channel pump, or the purchase price, whichever is smaller. In May, the FDA ordered Deerfield, Illinois-based Baxter to recall and destroy all 200,000 of its Colleague infusion pumps in the US due to “a longstanding failure to correct many serious problems with the pumps”. Baxter was ordered to refund customers or replace the pumps at no cost (www.clinica.co.uk, 4 May 2010).

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