Events

Recall of Device Recall Plum A Infusion Pump with Hospira MedNet Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64542
  • Event Risk Class
    Class 2
  • Event Number
    Z-2682-2017
  • Event Initiated Date
    2013-02-01
  • Event Date Posted
    2017-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154421
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
  • Action
    Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.

Device

Device Recall Plum A Infusion Pump with Hospira MedNet Software
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, 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 U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
  • Product Description
    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.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA