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FDA Device recall Z-0289-2014

The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used fo…

On 2013-11-20 the FDA classified a Class II recall of The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used fo… by Hospira, citing plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the press….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0289-2014
ClassificationClass II
Statusterminated
Initiated2013-02-01
Published2013-11-20
Last updated2026-09-13 11:53 UTC
CompanyHospira
DistributionUS

Product

The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Reason

Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken

Identifiers

code_info
1) List Number 20678; Serial Numbers: 15541001 , 15541011 , 15541021 , 15541031 , 15541041 , 15541051 , 15541061…1) List Number 20678; Serial Numbers: 15541001 , 15541011 , 15541021 , 15541031 , 15541041 , 15541051 , 15541061 , 15541071 , 15541081 , 15541091 , 15541101 , 15541111 , 15541121 , 15541131 , 15541141 , 15541151 , 15541161 , 15541171 , 15541181 , 15541191 , 15541201 , 15541211 , 15541231 , 15541241 , 15541261 , 15541271 , 15541281 , 15541291 , 15541301 , 15541311 , 15541321 , 15541331 , 15541341 , 15541351 , 15541361 , 15541371 , 15541381 , 15541391 , 15541401 , 15541411 , 15541421 , 15541431 , 15541441 , 15541451 , 15541461 , 15541471 , 15541481 , 15541491 , 15541501 , 15541511 , 15541521 , 15541531 , 15541541 , 15541551 , 15541561 , 15541571 , 15541581 , 15541591 , 15541601 , 15541611 , 15541621 , 15541631 , 15541641 , 15541651 , 15541661 , 15541671 , 15541681 , 15541691 , 15541701 , 15541711 , 15541721 , 15541731 , 15541741 , 15541751 , 15541761 , 15541771 , 15541781 , 15541791 , 15541801 , 15541811 , 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2014%22

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