Hospira Inc., A Pfizer Company recalls Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of ther…

Recall date

December 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1682-2017

FDA classification

Class II

Brand / firm

Hospira Inc., A Pfizer Company

Sold / distributed

Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain

Why it was recalled

Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss results in battery power operation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions