Z-2728-2016Class II

Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of...

Name: Z-2728-2016 Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of...
Creator: Hospira Inc.
Published: 2013-02-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-02-06 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple... on 2013-02-06. FDA classified it as Class II and gives the reason as "The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy". 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-2728-2016
Classification: Class II
Status: Terminated
Initiated: 2013-02-06
Posted: 2016-09-06
Terminated: 2016-11-14
Recalling firm: Abbott Medical
Product: Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose 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.
Product code: FRN Pump, Infusion
Reason for recall: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.
Quantity in commerce: 357,778 total
Distribution: United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
Product codes and lots: List number 12348, Serial Numbers: 13740156, 13740256, 13740266, 13740351, 13740380, 13740451, 13740508, 13740612, 13740632, 13740731, 13740732, 13740733, 13740734, 13740735, 13740736, 13740737, 13740738, 13740739, 13740740, 13740741, 13740742, 13740743, 13740744, 13740745, 13740746, 13740747, 13740748, 13740749, 13740750, 13740751, 13740752, 13740753, 13740754, 13740755, 13740756, 13740757, 13740758, 13740759, 13740760, 13740761, 13740762, 13740763, 13740764, 13740765, 13740766, 13740767, 13740768, 13740769, 13740770, 13740771, 13740772, 13740773, 13740774, 13740775, 13740776, 13740777, 13740778, 13740779, 13740780, 13740781, 13740782, 13740783, 13740784, 13740785, 13740786, 13740787, 13740788, 13740789, 13740790, 13740791, 13740792, 13740793, 13740794, 13740795, 13740796, 13740797, 13740798, 13740799, 13740800, 13740801, 13740802, 13740803, 13740804, 13740805, 13740806, 13740807, 13740808, 13740809, 13740810, 13740811, 13740812, 13740813, 13740814, 13740815, 13740816, 13740818, 13740819, 13740820, 13740821, 13740822, 13740823, 13740824, 13740825, 13740826, 13740827, 13740828, 13740829, 13740830, 13740831, 13740832, 13740833, 13740834, 13740835, 13740836, 13740837, 13740838, 13740839, 13740840, 13740841, 13740842, 13740843, 13740844, 13740845, 13740846, 13740847, 13740848, 13740849, 13740850, 13740851, 13740852, 13740853, 13740854, 13740855, 13740856, 13740857, 13740858, 13740859, 13740860, 13740861, 13740862, 13740863, 13740864, 13740865, 13740866, 13740867, 13740868, 13740869, 13740870, 13740871, 13740872, 13740873, 13740874, 13740875, 13740876, 13740877, 13740878, 13740879, 13740880, 13740881, 13740882, 13740883, 13740884, 13740885, 13740886, 13740887, 13740888, 13740889, 13740890, 13740891, 13740892, 13740893, 13740894, 13740895, 13740896, 13740897, 13740898, 13740899, 13740900, 13740901, 13740902, 13740903, 13740904, 13740905, 13740906, 13740907, 13740908, 13740909, 13740910, 13740911, 13740912, 13740913, 13740914, 13740915, 13740916, 13740917, 13740918, 13740919, 13740920, 13740921, 13740922, 13740923, 13740924, 13740925, 13740926, 13740927, 13740928, 13740929, 13740930, 13740977, 13740980, 13740982, 13740986, 13740994, 13741025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2728-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2722-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2723-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2724-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2725-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2726-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2727-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2728-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2729-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06
Z-2730-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-06

Product code FRN

K081412Class IIPlum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. / cleared 2008-12-17

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)