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.
FDA Recall Z-0863-2016 · Posted None
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Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2015-12-22
Date Terminated2016-11-28
Product Quantity6634 units.
Reason for Recall
Potential for the Symbiq pole clamp assemblies to be missing the
rubber stop pad.
Firm Action
On December 22, 2015 Stericycle, Inc. sent an URGENT MEDICAL DEVICE CORRECTION notification to direct consignees of record via traceable mailing. The notification included a description of the recall, risk to health information and necessary actions to be performed by the direct account. These include:
an inspection of the affected devices for missing rubber stop pad on the Symbiq pole clamp assemblies at the direct accounts.If missing rubber stop pads were discovered they were advised to contact Hospira's Advanced Knowledge Center at 1-800-241-4002, option 4, to receive a replacement pole clamp assembly or be directed to a field Service Engineer who will replace the pole clamp.
Hospira ALso advised informing healthcare professionals at their institution about the issue and complete the attached reply form and return it by e-mail or fax at:
1-800-441-4100/1-800-241-4002 or at [email protected]
Finally customers where advised to notify FDA of any adverse events through FDA's MedWatch Adverse Event Reporting program.
Root Cause
Nonconforming Material/Component
Distribution Pattern
U.S. consignees nationwide.*** Foreign consignees in: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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