Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Plum 360 is a large volume infuser capable of Recalled by Hospira Inc. Due to Firm's investigation determined that the Proximal Occlusion Alarms...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hospira Inc. directly.
Affected Products
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360 infuser features Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without is disconnecting the patient line. The Plum 360 can act as a stand-alone infuser, or in conjunction with the Hospira MedNet software to provide medication safety software at the point of care, with customized drug libraries to support hospital defined protocols by clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and Hospira MedNet software interface with other hospital systems such as Electronic Health records, Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and there systems. Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and wireless 802.11 a/b/g/ networking capabilities. The Plum 360 infuser interfaces with Hospira MedNet application software to download drug library and infuser software updates and enable auto-programming of the infuser.The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Quantity: 1490 infusion pumps.
Why Was This Recalled?
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
Where Was This Sold?
U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
About Hospira Inc.
Hospira Inc. has 245 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report