Recall Z-0863-2016— Hospira Inc.

Name: FDA recall Z-0863-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-22

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2015-12-22, terminated 2016-11-28. It names one FDA 510(k) clearance: K110901. Product: The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.. Reason: Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-22
Terminated: 2016-11-28
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 Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.

Reason for recall

Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.

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