Events

Recall of Device Recall The Plum A Infusion System

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
    69336
  • Event Risk Class
    Class 1
  • Event Number
    Z-1073-2015
  • Event Initiated Date
    2014-07-02
  • Event Date Posted
    2015-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130256
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    One lot of alarm assemblies used in plum a+ and plum a+3 infusion pumps may fail to sound at all volume levels.
  • Action
    Hospira sent an Urgent Medical Device Correction letter dated July 2, 2014, to all affected customers. The letter notified customers that Hospira will be contacting them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test. Additionally, the letter included instructions for customers to: 1) inform potential users of this notification; 2) complete and return the attached reply form; and, 3) if the products were further distributed, notify those accounts of this recall and ask them to contact Stericycle at 888-912-7350 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. A second URGENT MEDICAL DEVICE CORRECTION letter dated July 16, 2014 was sent to all customers of record because the initial letters may have contained errors in the attached data files listing the potentially affected devices at the customer's' facility. The instructions to the customer were unchanged from the original letter. For questions regarding this recall call 800-441-4100.

Device

Device Recall The Plum A Infusion System
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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, Ecuador, France, Israel, Italy, Mexico, Oman, Peru, Saudi Arabia, Spain, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    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.
  • 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