FDA Makes Class I Recall for Infusion Pumps

infusion pumpsThe FDA initiated a class I recall its strictest of two infusion pumps released by a single company, due to a device error which may fail to recognize in-line air in infusions. Device manufacturer Hospira warned that failure to make corrective actions before device use may cause air to be delivered to the patient and cause serious injury or death. The company has not received any adverse event reports related to device failure.

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Shipment of Alaris infusion pumps resumed

CardinalCardinal Health Inc has received FDA clearance to resume shipments of its flagship line of infusion pumps after problems triggered a halt to shipping earlier this year. The company had put the shipping of the patient-controlled modules for the pumps, which allow a patient to press a button for pain medication, on hold in March. It would now immediately resume customer implementations of its Alaris(R) PC units and PCA (Patient Controlled Analgesia) modules.