Z-2677-2017Class II

The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple...

Name: Z-2677-2017 The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple...
Creator: ICU
Published: 2013-02-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-02-01 / Terminated

FDA source

ICU began a recall of The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical... on 2013-02-01. FDA classified it as Class II and gives the reason as "A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2677-2017
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2017-07-07
Terminated: 2018-05-31
Recalling firm: Abbott Medical
Product: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.
Product code: FRN Pump, Infusion
Reason for recall: A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
FDA root cause: Other
Action: Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.
Quantity in commerce: 71 units
Distribution: Nationwide, Worldwide
Product codes and lots: List number: 11973 Serial Numbers 12570148 12570150 12570154 12570163 12570170 12570177 12570204 12570211 12570212 12570255 12570270 12570319 12570359 12570385 12570413 12570425 12570455 12570487 12570662 12570695 12570854 12570915 12571080 12571243 12571437 12571631 12571692 12571776 12571826 12571835 12571837 12571842 12571877 12571880 12571886 12572317 12572369 12572586 12572909 12573547 12573567 12573837 12573990 12574424 12574501 12574524 12574556 12574599 12574619 12574731 12574749 12574853 12574858 12574860 12574865 12574961 12575626 12575698 12575886 12576125 12576443 12576485 12576518 12576593 12576609 12576710 12576722 12577271 12577685 12578856 12579183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2677-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2675-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2676-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2677-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2678-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2679-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2680-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2681-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2682-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10
Z-2683-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

Product code FRN

K070398Class IIHospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. / cleared 2007-04-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)