Credit: Elise Amendola
Hospira, Inc. has announced a nationwide recall of 2 lots of Hemoset Dual Channel Plum Sets, which are used to administer blood products.
The affected lots—28005-5H and 34100-5H (list number 11241-03)—contain an incorrect component.
Using these sets, which were distributed across the US, could result in the over-delivery of blood products.
However, Hospira has not received any reports of adverse events associated with the sets. The recall is a precautionary measure.
Possible risk associated with the sets
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 one of the sets being recalled, the blood product will be delivered at its intended dosage.
However, if one of the affected sets is removed from the Plum infusion pump and used in a gravity infusion, there is a risk of over-delivering blood products, due to the incorrect component—a lower lid.
In a gravity delivery, the correct lower lid dispenses 15 drops per mL. But the incorrect lower lid dispenses 10 drops per mL. If a caregiver does not realize that each drop contains more volume, over-delivery could occur.
Over-delivery of blood products in the populations at greatest risk (eg, neonates and patients with heart and/or kidney failure) may result in injuries that require medical intervention. These injuries are expected to fully resolve with medical intervention.
Steps to take
The sets impacted by the recall were distributed to US healthcare and veterinary facilities from May 2013 through December 2013.
Customers should check their inventory and immediately quarantine any affected sets. They should also inform individuals who might use the sets about the recall.
The affected sets should be returned to Stericycle. To do so, call 1-888-240-4282, Monday through Friday between 8 am and 5 pm Eastern Time.
For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187.
Adverse reactions or quality problems associated with the use of these sets can be reported to the US Food and Drug Administration’s MedWatch Adverse Event Reporting Program.
