Recall Z-1847-2013 ยท FRN Pump, Infusion
Hospira Inc.
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
| Date | Aug 1, 2013 (initiated Feb 4, 2013) |
| Status | Terminated |
| Reason | The devices secondary audio signal fails to activate. |
| Root cause | Process control |
| Action | Hospira sent a Urgent Device Field Correction letter dated February 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In addition, letters were sent by e-mail to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites February 5, 2013. The letter was also posted on the Hospira website February 4, 2013. Customers were requested to return a reply form indicating they have received the letter and notified their users. For further inquiries please contact Hospira Global Compl |
| Quantity | 2,791 units |
| Distribution | US Distribution including the states of AL, CA, CT, DE, FL, HI, IA, IL, IN, LA, MA, MD, ME, MI, MN, NC, NJ, NY, PA, SD, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET Hospira, Inc., Mar 5, 2012 |