Class 1 Recall: Hospira Plum A+ and Plum A+3 Infusion Systems Alarm Volume Failure
The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it.
Wed May 28 2014
Recall Class: Class I
Date Recall Initiated: May 28, 2014
Devices: Plum A+ infusion pumps and Plum A+3 infusion pumps
A full list of products being recalled can be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130257
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=130256
Manufacturing and Distribution dates: July 2012 to May 2014
Use: An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home. These devices are primarily used by health care providers.
Recalling Firm: Hospira Inc.
275 N Field Dr.
Lake Forest, Illinois
60045-2579
Reason for Recall: The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for a long delay before a health care professional becomes aware of the need to restore therapy.
No injuries, illnesses, or deaths associated with this defect have been reported. However, for patients receiving critical intravenous medication, there is a risk of injury resulting from this prolonged interruption in therapy.
There is the possibility of serious patient injury or death.