Recall Z-0306-2017 ยท FRN Pump, Infusion
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
| Date | Feb 4, 2013 |
| Status | Terminated |
| Reason | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury. |
| Root cause | Software design |
| Action | Hospira sent an Urgent Device Field Correction notice dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the steps provided in the letter while Hospira is developing a software change. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to contact Stericycle at 1-888-201-9332. For questions regarding this recall call 224-212-4892. |
| Quantity | 35,596 devices in total |
| Distribution | Worldwide Distribution - USA (nationwide) and 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 |