The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There’s an interesting calculation of Baxter’s expected loss (though, Baxter is hoping to replace the Colleague pumps with other Baxter pumps).
See our prior post on the Baxter pump recall here.