Baxter Healthcare has received conditional approval from the FDA for the corrective action plan it developed for COLEAGUE infusion pumps — this comes three months following FDA’s seizure of COLLEAGUE pumps at the company’s northern Illinois warehouses over design and user interface issues.
Baxter’s plan is accompanied by submission last week of an updated 510(k) pre-market notification filing with FDA, for which the company anticipates agency notification within 90 days. Baxter plans to begin deployment of the corrective actions in the U.S. following FDA's final approval of the corrective action plan, which is conditioned upon successful 510(k) clearance.
Pumps currently in the market continue to be safe to use when operated according to the user manual and instructions contained in previous customer communications, according to Baxter. Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals and over 50,000 are used abroad.