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.
Recall
- Recall Number
- Z-0863-2016
- Event Number
- 73104
- Firm
- Hospira Inc.
- FEI Number
- 3013319212
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 22, 2015
- Terminated
- November 28, 2016
- Address
- 275 N Field Dr, Lake Forest, IL, 60045-2579
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.
Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad.
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.
U.S. consignees nationwide.*** Foreign consignees in: Canada.
6634 units.