Events

Recall of Device Recall Plum 360" Infusion System with Hospira Mednet", Smart Card Plug 'N Play, Upgrade Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ICU Medical 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
    77624
  • Event Risk Class
    Class 2
  • Event Number
    Z-3031-2017
  • Event Initiated Date
    2017-06-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156896
  • 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
    Potential for the connectivity engine module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. this would delay initiation of therapy or interrupt an infusion.
  • Action
    ICU Medical sent an Urgent - Medical Device Correction letter dated June 15, 2017, to all affected customers. The firm contracted with Stericycle for recall notification, response tracking, and effectiveness checks. The customer notification was also posted on icumed.com. The notification requested that consignees verify their unit is working and testing the CE Module. If the unit's CE Module is loose or a blank display occurs, customers are asked to record the S/N and contact ICU Medical Technical Service Support Center at 800-241-4002, option 4. If the unit is functional, return to service. If the unit powers down without an alarm notification, use another unit and contact ICU Medical Global Complaint Management at 800-441-4100. The firm will contact reporting consignees of correction scheduling when parts become available. Adverse reactions or quality problems related to this problem should be reported to FDA's MedWatch Adverse Event Reporting Program by mail, fax, or online. Consignees are advised to inform potential users within their organization of the recall and to complete the recall response form attached to recall notification. The completed response form can be returned by email to ICUMedical7087@stericycle.com or faxed to 855-544-4814. If product was distributed, ask customers to request them to contact Stericycle for a copy of recall notification at 855-544-4813.

Device

Device Recall Plum 360" Infusion System with Hospira Mednet", Smart Card Plug 'N Play, Upgrade M...
  • Model / Serial
    Model No. 30010
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Plum 360 Infusion System
  • Manufacturer
    ICU Medical Inc

Manufacturer

ICU Medical Inc
  • Manufacturer Address
    ICU Medical Inc, 600 N Field Dr, Lake Forest IL 60045-4835
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA