Recall Z-1847-2013— Hospira Inc.

Name: FDA recall Z-1847-2013
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 2016-11-07. It names one FDA 510(k) clearance: K110901. Product: The Hospira Symbiq Infusion System is 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.. Reason: The devices secondary audio signal fails to activate..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Terminated: 2016-11-07
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

The Hospira Symbiq Infusion System is 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.

Reason for recall

The devices secondary audio signal fails to activate.

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