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
FDA Recall Z-1682-2017 · Posted None
Recalling FirmHospira Inc., A Pfizer Company
Recall StatusTerminated
Product CodeFRN
Date Initiated2016-12-30
Date Terminated2019-07-09
Product Quantity62,847 units
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.
Firm Action
On 12/30/2016, firm sent notification of the recall to Hospira direct consignees of record via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Effectiveness of the communication will be confirmed by phone call with direct consignees who do not respond. The final disposition of the recalled product will be field correction (firm will contact consignees to upgrade the software in their Plum 360 infusion pumps).
Root Cause
Software in the Use Environment
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.