—#112397

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550, K110901
Affected lot / code info: List Number 16027-01, all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada

Timeline

Recall initiated: 2012-08-29
Posted by FDA: 2012-10-19
Terminated: 2017-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.