Company: Hospira, Inc.
Date of Enforcement Report 4/5/2017
Class lI:
PRODUCT
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
Recall Number Z-1682-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Lake Forest, IL on 12/30/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
862,847 units
DISTRIBUTION
Nationwide and Internationally
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