FDA Device recall Z-0284-2014
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for…
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for… 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0284-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-01 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | US |
Product
The Plum A+ 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+ 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+ 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 11971; Serial Numbers: 13120009 , 13120017 , 13120018 , 13120019 , 13120026 , 13120028 , 13120037…1) List Number 11971; Serial Numbers: 13120009 , 13120017 , 13120018 , 13120019 , 13120026 , 13120028 , 13120037 , 13120041 , 13120042 , 13120044 , 13120057 , 13120058 , 13120068 , 13120071 , 13120074 , 13120075 , 13120082 , 13120096 , 13120103 , 13120104 , 13120107 , 13120108 , 13120109 , 13120115 , 13120128 , 13120138 , 13120143 , 13120153 , 13120160 , 13120164 , 13120168 , 13120171 , 13120174 , 13120177 , 13120186 , 13120187 , 13120200 , 13120205 , 13120220 , 13120222 , 13120223 , 13120226 , 13120231 , 13120235 , 13120237 , 13120238 , 13120239 , 13120247 , 13120248 , 13120249 , 13120251 , 13120253 , 13120262 , 13120270 , 13120271 , 13120277 , 13120279 , 13120285 , 13120293 , 13120294 , 13120295 , 13120297 , 13120303 , 13120310 , 13120311 , 13120314 , 13120320 , 13120329 , 13120343 , 13120344 , 13120346 , 13120353 , 13120354 , 13120357 , 13120359 , 13120365 , 13120366 , 13120367 , 13120370 , 13120385 , 1 |
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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-0284-2014%22
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