Reported Jun 15, 2016 · Terminated
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as…
Hospira Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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.
- Lot codes and dates
- PLum A+
- devices with the following list numbers
12391-04-2512391-22-0512391-23-0512391-23-1512391-36-0712391-54-0512391-88-0112391-88-0212391-88-0312391-88-0412391-88-0520792-04-2520792-13-0920792-57-1520792-65-0120792-65-02 and 20792-88-69
- Amount recalled
- 2567 Plum A+ infusion pumps.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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