FDA recall record

Hospira The Symbiq infusion pump is a device used in a health care facility to pump fluids recall — FDA Z-0863-2016

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

Class IIclassification
Z-0863-2016official record ID
Mar 2, 2016report date

Recall record at a glance

Official recordZ-0863-2016
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmHospira Inc.
Report dateMar 2, 2016
Recall initiation dateDec 22, 2015
Quantity6634 units.
LocationLake Forest, IL, United States

Official 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.

Why the product was recalled

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

Distribution information

U.S. consignees nationwide.*** Foreign consignees in: Canada.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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