—#75724

Product

Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. Intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041550
Affected lot / code info: All products manufactured between 12/19/06 to 12/02/08 with list numbers 16026-04-01/03/04, 51/52, 79/80 and 81/82, or 16027-04-01/03/04, 51/52, 53/54, 79/80, and 81/82.

Why it was recalled

Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.

Root cause (FDA determination)

Software design

Action the firm took

Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements.

Recalling firm

Firm: Hospira Inc
Address: 755 Jarvis Dr, Morgan Hill, California 95037-2810

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Canada and Australia.

Timeline

Recall initiated: 2008-12-03
Posted by FDA: 2009-02-27
Terminated: 2012-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.