Z-1832-2016Class II

The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as...

Name: Z-1832-2016 The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as...
Creator: Hospira Inc.
Published: 2016-03-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2016-03-25 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of 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... on 2016-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1832-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-06-03
Terminated: 2018-03-06
Recalling firm: Abbott Medical
Product: 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 code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 2016, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue. :
Quantity in commerce: 1490 infusion pumps.
Distribution: U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
Product codes and lots: PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03
Z-1833-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03

Product code FRN

K141789Class IIPlum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for Plum a+ Infusion System UpgradeHospira, Inc. / cleared 2015-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)