Hospira Inc. recalls The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environm…

Recall date

July 2, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1072-2015

FDA classification

Class I

Brand / firm

Hospira Inc.

Sold / distributed

Worldwide Distribution - USA including AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Brazil, Canada, Colombia, Ecua…

Why it was recalled

One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.