FDA Device recall Z-1833-2016
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and…
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and… by Hospira, citing firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specif….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1833-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-25 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | n/a |
Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.
Reason
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
Identifiers
| code_info | PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391…PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391-54-05, 12391-88-01, 12391-88-02, 12391-88-03, 12391-88-04, 12391-88-05, 20792-04-25, 20792-13-09, 20792-57-15, 20792-65-01, 20792-65-02 and 20792-88-69. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1833-2016%22
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