Z-0944-2009

Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general...

Name: Z-0944-2009 Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general...
Creator: Hospira Inc
Published: 2008-12-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-12-03 / Terminated / root cause: software

FDA source

Hospira Inc began a recall of Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by... on 2008-12-03. The reason FDA records is "Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0944-2009
Status: Terminated
Initiated: 2008-12-03
Posted: 2009-02-27
Terminated: 2012-04-03
Recalling firm: Abbott Medical
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.
Product code: FRN Pump, Infusion
Reason for recall: Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: combined 11,840 units
Distribution: Worldwide Distribution --- including USA and countries of Canada and Australia.
Product codes and lots: 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.

Product code FRN

K041550Class IIHospira Phoenix Infusion System with Hospira Mednet SoftwareAbbott Laboratories / cleared 2004-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)