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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hospira Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1832-2016
Related Recalls
Presence of Particulate Matter: human hair found within an internal sample syringe.
Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.