FDA Issues Class I Recall for Hospira Blood Kits

The U.S. Food and Drug Administration (FDA) has issued its highest-risk Class 1 recall on Hospira Inc. blood kits after one patient died due to delayed treatment caused by a punctured blood bag. The Lake Forest, Ill.-based device company discovered the patient had died due to the piercing pin in one of its kits puncturing the outer wall of a blood bag.

Hospira warned healthcare providers of the risk of piercing pins in certain blood kits leading to blood leaks, putting healthcare providers at risk of exposure to blood products. Hospira denies that its products need to be recalled and suggests there is no reason for healthcare workers to return or stop using its products. The company is, however, handing out blunter piercing pins to avoid further punctures.

In a letter to customers, Hospira identified the affected products and advised providers to carefully follow protocol for spiking blood bags. “Hospira recommends users exercise EXTREME CAUTION when piercing blood bags with a Hospira blood set referenced above,” Chris Eustace, vice president of quality device operations, wrote. “Make sure that all instructions for use included with the blood bag and your facility’s protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag.”

The letter also warned providers of potential health risks. “If the piercing pin…punctures the outer wall of a blood bag, it may result in spillage of the blood products stored in the bag, resulting in a delay in therapy. Spillage of blood products has the potential to result in exposure to the healthcare professional. The severity of the delay in therapy is dependent upon the underlying condition of the patient. Delay in has a worst case potential to result in significant injury or death,” Eustace’s letter states.   

The blood bags affected by the recall were distributed to healthcare institutions between July 2011 and February 2013.

The FDA only issues Class 1 recalls for product issues that have the potential to cause serious adverse effects or death.