Z-2391-2010

Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number...

Name: Z-2391-2010 Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-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 Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54... on 2010-02-22. The reason FDA records is "The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container". 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-2391-2010
Status: Terminated
Initiated: 2010-02-22
Posted: 2010-09-09
Terminated: 2011-04-01
Recalling firm: Abbott Medical
Product: Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54, Distributed by: Hospira, Inc. Morgan Hill, CA
Product code: FRN Pump, Infusion
Reason for recall: The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.
Root cause tag: design
FDA root cause: Device Design
Action: Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002.
Distribution: Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, 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)