Device recall: Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of…

Class II FDA enforcement event 76253. Recall start date: 30 Dec 2016. Status in the FDA record: Terminated. Termination date: 9 Jul 2019.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Hospira Inc., A Pfizer Company started this device recall on 30 Dec 2016. The firm address in the FDA record is in Lake Forest, IL. FDA put the recall in Class II. FDA event 76253 has 1 product record. The first FDA enforcement report date is 5 Apr 2017. The record gives the status Terminated, with the termination date 9 Jul 2019.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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…

Recalling firm

Hospira Inc., A Pfizer Company, Lake Forest, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 76253: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1682-2017	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	62,847 units	Class II	Terminated	5 Apr 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Hospira Inc., A Pfizer Company
Initiated	Product (first record)	Type	Class	Records
20 Feb 2018	Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, I	Drug	Class II	1
6 Jul 2017	Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma L	Drug	Class III	1
18 May 2017	Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC	Drug	Class II	1
10 Feb 2017	METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc	Drug	Class II	1
24 Jan 2017	Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous	Drug	Class I	1
16 Sep 2016	Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, I	Drug	Class II	2
4 Aug 2016	Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, H	Drug	Class I	1
28 Jul 2016	Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combinati	Device	Class II	1

Hospira Inc., A Pfizer Company: all 9 events

Official channels

FDA enforcement report Z-1682-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 76253. https://recallregister.com/fda/ii/76253/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: 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…
What quantity of product is in FDA event 76253?: The FDA record gives this quantity: 62,847 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.