Hospira infusion pump recall gets class I notice

The US FDA has given the recall of Hospira’s Symbiq infusion pump a class I classification. Hospira notified customers on 9 April that the product could fail to detect the delivery of air to a patient at the end of an infusion; this could potentially cause serious injury or death. On 11 June, the company updated its communications to customers, saying that users do not have to remove or stop using the Symbiq pump. The device is used for the delivery of fluids including solutions, drugs, nutrition, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. Hospira said that “the root cause for the failure to detect air in line continues to be investigated”.