Z-0127-2011

Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number...

Name: Z-0127-2011 Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number...
Creator: Hospira Inc
Published: 2010-02-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-02-22 / Terminated / root cause: design

FDA source

Hospira Inc began a recall of Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82... on 2010-02-22. The reason FDA records is "Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0127-2011
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-10-22
Terminated: 2013-12-03
Recalling firm: Abbott Medical
Product: Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 53/54, Distributed by: Hospira, Inc. Morgan Hill, CA
Product code: FRN Pump, Infusion
Reason for recall: Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.
Root cause tag: design
FDA root cause: Device Design
Action: Hospira issued a Recall Notification letter dated October 4, 2010, updating the Urgent Device Field Correction letter dated February 22, 2010, ideentifying the affected products, the issue prompting the recall, and actions to be taken by customers. Customers are to examine their inventory to determine if they have any of the affected products, and recommended to remove them from service in critical care areas, and contact Hospira to schedule removal and replacement of the motor. Replace affected devices with a loaner or corrected back-up pump if available. Custoemrs can contacvtd Hospira Global Product Safety and Complaints at 1-800-441-4100, and Technical Support Operations at 1-800-241-4002.
Distribution: Worldwide Distribution: USA and the coutnries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
Product codes and lots: All units of these List Numbers.

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)