Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 15, 2016
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 infuse
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 specif…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hospira Inc. recalled The Plum 360 is a large volume infuser capable of delivering fluids for a variety of ther… - a moderate-severity action.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of ther… was recalled by Hospira Inc. in June 15, 2016. Reason: Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to t…. Check the official notice for the remedy. Verify recall #Z-1832-2016 with the FDA Devices before acting.
The recall
Hospira Inc. issued this moderate-severity FDA Devices recall-Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to t….
- Moderate
- severity level
- Class II
- classification
- June 15, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1832-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1832-2016) was formally reported on June 15, 2016, with the manufacturer initiating the action on March 25, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 1490 infusion pumps..
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1490 infusion pumps.
Related Recalls
6
3 from same agency
Product 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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1832-2016 |
| Date reported | June 15, 2016 |
| Date initiated | March 25, 2016 |
| Recalling firm | Hospira Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 1490 infusion pumps. |
| Distribution | U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1832-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 1490 infusion pumps..
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1832-2016.
Where was the recalled product distributed? ▼
Distribution: U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1832-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 15, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.