Z-2381-2010

Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively

Name: Z-2381-2010 Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively
Creator: Hospira Inc
Published: 2010-03-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-03-26 / Terminated / root cause: design

FDA source

Hospira Inc began a recall of Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively on 2010-03-26. The reason FDA records is "If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result". 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-2381-2010
Status: Terminated
Initiated: 2010-03-26
Posted: 2010-09-08
Terminated: 2012-03-30
Recalling firm: Abbott Medical
Product: Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.
Product code: FRN Pump, Infusion
Reason for recall: If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.
Root cause tag: design
FDA root cause: Device Design
Action: Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.
Quantity in commerce: 28485 units
Distribution: Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
Product codes and lots: List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 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)