Recall of Hospira Hemostat dual channel Plum set due to risk of over-delivery


FDA report “Hospira identified that an incorrect set component was supplied and used during the manufacturing process of the impacted product lots. The Hemostat Dual Channel Plum Set is designed to administer blood and blood products via the Plum infusion pump. If the Plum infusion pump is used with the affected product, the blood product will be delivered at its intended dosage and there is no risk of over-delivery. If the affected product is removed from the Plum infusion pump and used in a gravity infusion, there is a risk that over-delivery may occur. Over-delivery of blood products in the populations at greatest risk (e.g. neonates, patients with heart and/or kidney failure, and other patients with conditions associated with susceptibility to volume overload) may result in injuries that require medical intervention. These injuries are expected to fully resolve with medical intervention.”

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