Hospira Inc.: Plum A+ Hyperbaric Infusion Pump. List Number 11005. 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.

Recall number

Z-2722-2016

Recalling firm

Hospira Inc.

Product

Plum A+ Hyperbaric Infusion Pump. List Number 11005. 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.

Status

Terminated

Initiated

2013-02-06

Posted

2016-09-06

Terminated

2016-11-14

Reason

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

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

357,778 total

Distribution

United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.

Lot, serial or model codes

List Number 11005. Serial numbers: 16792201,  16792202,  16792205,  16792206,  16792208,  16792209,  16792210,  16792211,  16792213,  16792216,  16792217,  16792219,  16792220,  16792222,  16792223,  16792224,  16792225,  16792226,  16792227,  16792228,  16792230,  16792232,  16792233,  16792234,  16792235,  16792236,  16792238,  16792239,  16792240,  16792241,  16792242,  16792244,  16792245,  16792246,  16792248,  16792249,  16792250,  16792251,  16792252,  16792253,  16792254,  16792255,  16792256,  16792257,  16792258,  16792259,  16792260,  16792261,  16792263,  16792264,  16792265,  16792266,  16792268,  16792269,  16792271,  16792272,  16792273,  18807402,  18807405,  18807406,  18807407,  18807408,  18807409,  18807410,  18807413,  18807414,  18807417,  18807418,  18807420,  18807421,  18807423,  18807427,  18807428,  18807429,  18807430,  18807431,  18807432,  18807433,  18807434,  18807439,  18807443,  18807444,  18807446,  18807449,  18807452,  18807453,  18807455,  18807456,  18807459,  18807463,  18807466,  18807472,  18807474,  18807478,  18807484,  18807485,  18807486,  18807490,  18807491,  18807494,  18807496,  18807499,  18807500,  18807501,  18807506,  18807509,  18807510,  18807511,  18807513,  18807514,  18807518,  18807523,  18807524,  18807529,  18807535,  18807536,  18807539,  18807540,  18807541,  18807542,  18807543,  18807545,  18807546,  18807556,  18807557,  18807568,  18807574,  18807575,  18807576,  18807578,  18807581,  18807584,  18807585,  18807586,  18807588,  18807589,  18807590,  18807591,  18807596,  18807597,  18807598,  18807599,  18807600,  18807601,  18807602,  18807604,  18807605,  18807607,  18807608,  18807609,  18807610,  18807611,  18807612,  18807613,  18807614,  18807617,  18807618,  18807619,  18807620,  18807623,  18807625,  18807626,  18807627,  18807628,  18807630,  18807631,  18807632,  18807633,  18807634,  18807636,  18807637,  18807639,  18807640,  18807695,  18807696,  18807697,  18807698,  18807699,  18807700.

510(k) numbers

["K081412"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3013319212

Firm city

Lake Forest

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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