Events

Recall of Device Recall Symbiq One Channel Infuser

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
    63056
  • Event Risk Class
    Class 1
  • Event Number
    Z-0069-2013
  • Event Initiated Date
    2012-08-29
  • Event Date Posted
    2012-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112396
  • 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
    The symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
  • Action
    Hospira sent an Urgent Device Correction letter dated August 29, 2012, to all affected customers. Customers have been informed of reports that the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. The users were instructed to complete and fax the enclosed reply card to 1-888-943-5180 or email it to Hospira194@stericycle.com indicating the number of infusers at the facility and if they notified their users throughout the facility. Wholesalers were asked to notify their customers. If they have further distributed the affected product, they should notify their accounts and ask them to contact Stericycle at 1-877-272-6141 to receive a reply form. For questions regarding this recall call 224-212-2000.

Device

Device Recall Symbiq One Channel Infuser
  • Model / Serial
    List Number 16026-01, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
  • Product Description
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 || Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
  • 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