PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 5, 2017 Initiated: December 30, 2016 #Z-1682-2017

Product Description

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

Reason for Recall

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.

Details

Units Affected
62,847 units
Distribution
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
Location
Lake Forest, IL

Frequently Asked Questions

What product 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. Recalled by Hospira Inc., A Pfizer Company. Units affected: 62,847 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2017. Severity: Moderate. Recall number: Z-1682-2017.

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