Recall Z-0306-2017— Hospira Inc.

Name: FDA recall Z-0306-2017
Creator: U.S. Food and Drug Administration
Published: 2013-02-04

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-02-04, terminated 2016-12-15. It names one FDA 510(k) clearance: K110901. Product: Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.. Reason: Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Terminated: 2016-12-15
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110901 — SYMBIQ INFUSION AND ADMINSTRATION SETHospira, Inc.·cleared 2012-03-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.

Reason for recall

Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.