Class 1 Device Recall Symbiq Two Channel Infuser

• Date Initiated by Firm: August 29, 2012
• Date Posted: October 19, 2012
• Recall Status: Terminated on March 15, 2017
• Recall Number: Z-0070-2013
• Recall Event ID: 63056
• 510(K)Number: K041550 K110901
• Product Classification: Pump, infusion - Product Code FRN
• Product: Symbiq Two 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 16027-01; ; 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
• Code Information: List Number 16027-01, all serial numbers
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Ms. Ileana Quinones; 224-212-2000
• Manufacturer 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 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 14,067 units
• Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES; 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.