Recall Z-0863-2016 ยท FRN Pump, Infusion
Hospira Inc.
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 C
| Date | Dec 22, 2015 |
| Status | Terminated |
| Reason | Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 6634 units. |
| Distribution | U.S. consignees nationwide.*** Foreign consignees in: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc., Mar 5, 2012 |