Touchscreen for Hospira Symbiq Infusion System, Models 16026 and 16027
Recall Class: Class I
Date Recall Initiated: August 29, 2012
Product: Symbiq Infusion System
Models and Serial Numbers:
- 16026 Symbiq One Channel Infuser
- 16027 Symbiq Two Channel Infuser
All serial numbers for these models are potentially affected by this recall.
Distribution Dates: All
Intended Use: The Symbiq infusion pump is a prescription device used to deliver controlled amounts of medications or other fluids to patients through intravenous, intra-arterial, epidural, and other acceptable routes of administration.
The touchscreen is used to control infusion pump settings for patient therapy.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Reason for Recall: 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 or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen before starting the infusion.
Health care providers experiencing the described issue should remove the impacted device from use and contact their institution's biomedical or clinical engineering department to perform the touchscreen test described in the Symbiq technical service manual. If the biomedical or clinical engineering department identifies that the device is not working properly, contact Hospira
Public Contact: Customers with questions may contact Hospira at 1-800-441-4100 (8am – 5pm CST, Monday-Friday).
FDA District: Chicago
FDA Comments: An Urgent Device Correction letter notifying customers of this recall was mailed by Stericycle, Inc, on behalf of Hospira on August 29, 2012. Customers were instructed not to return affected Symbiq infusion pumps. In addition, the letter lists steps that users may take to confirm that infusion settings are correctly entered as well instructions for how to stop an infusion.
Customers were also instructed to complete and return a reply card that was included with the letter, to indicate the number of infusion systems at their facility and whether clinicians throughout the facility had been notified of the touchscreen issue. Wholesalers were asked to notify their customers.
Hospira has determined that the touchscreen issue is related to software and the company is developing design improvements to correct it. Once the design and development activities are complete, Hospira will notify customers to arrange for the correction of Symbiq Infusers.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, by regular mail, by telephone, or by FAX.