Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 Z-1682-2017

U.S. FDA — Device Enforcement · United States · 2016-12-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1682-2017
Date of alert
2016-12-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hospira Inc., A Pfizer Company
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
19985403
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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