Z-0070-2013 Class I Terminated
FDA device recall Z-0070-2013 was initiated by Hospira Inc. on Aug 29, 2012 and is designated Class I. 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… The recall status is terminated (terminated Mar 15, 2017). Affected quantity: 14,067 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Aug 29, 2012
- Termination Date
- Mar 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,067 units
Product Description
Symbiq Two 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 16027-01 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
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada
Code Information
List Number 16027-01, all serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0070-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026