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.
This recall has been terminated (originally issued February 27, 2009).
- Company
- Hospira Inc
- Recall Initiated
- December 3, 2008
- Posted
- February 27, 2009
- Terminated
- April 3, 2012
- Recall Number
- Z-0944-2009
- Quantity
- combined 11,840 units
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.
Distribution
Worldwide Distribution --- including USA and countries of Canada and Australia.
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.
Root Cause
Software design
Action Taken
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.