Z-1895-2010

Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA...

Name: Z-1895-2010 Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA...
Creator: Hospira Inc
Published: 2010-04-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-04-09 / Terminated / root cause: design

FDA source

Hospira Inc began a recall of Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora... on 2010-04-09. The reason FDA records is "Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation". 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-1895-2010
Status: Terminated
Initiated: 2010-04-09
Posted: 2010-07-02
Terminated: 2013-12-03
Recalling firm: Abbott Medical
Product: Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc. Morgan Hill, CA and Manufactured by: Hospira Inc, La Aurora, Heredia, Costa Rica. Intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
Product code: FRN Pump, Infusion
Reason for recall: Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
Root cause tag: design
FDA root cause: Device Design
Action: Hospira issued a "Urgent: Medical Device Recall Notification" dated June 11, 2010 to update a previously issued Clinical Bulletin. Customers were informed of the issue and instructed on proper mitigation steps to further avoid the issue associated with the affected product. Consignees were asked to complete and return the Reply Form. For further information, contact Hospira Technical Support Operations at 1-800-332-4002, 6AM to 4PM PST, Monday through Friday.
Quantity in commerce: 28,485 total
Distribution: Worldwide Distribution -- United States (AL, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA and WA), and Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and United Arab Emirates.
Product codes and lots: All units including List Number Configurations: 16027-04-01/03/04,51/52,53/54, 79/80,81/82,83/84,87/88 and 89/90; 16027-27-89/90; 16027-13-25/26,53/54.

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)