Hospira Inc.: Medical Device Recall in 2016 - (Recall #: Z-1833-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 25, 2016

Date Posted: June 15, 2016

Recall Number: Z-1833-2016

Event ID: 73799

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2567 Plum A+ infusion pumps.

Code Information:

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.

Distribution Pattern:

U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated