Z-0069-2013Class I

Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc...

Name: Z-0069-2013 Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc...
Creator: Hospira Inc.
Published: 2012-08-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-08-29 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica... on 2012-08-29. FDA classified it as Class I and gives the reason as "The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user...". 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-0069-2013
Classification: Class I
Status: Terminated
Initiated: 2012-08-29
Posted: 2012-10-19
Terminated: 2017-03-15
Recalling firm: Abbott Medical
Product: Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
Product code: FRN Pump, Infusion
Reason for recall: The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.
Root cause tag: design
FDA root cause: Device Design
Action: Hospira sent an Urgent Device Correction letter dated August 29, 2012, to all affected customers. Customers have been informed of reports that the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. The users were instructed to complete and fax the enclosed reply card to 1-888-943-5180 or email it to [email protected] indicating the number of infusers at the facility and if they notified their users throughout the facility. Wholesalers were asked to notify their customers. If they have further distributed the affected product, they should notify their accounts and ask them to contact Stericycle at 1-877-272-6141 to receive a reply form. For questions regarding this recall call 224-212-2000.
Quantity in commerce: 19,614 units
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
Product codes and lots: List Number 16026-01, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0069-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0069-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-19
Z-0070-2013	Class I	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-19

Product code FRN

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)