Recall Z-2790-2016 ยท FRN Pump, Infusion
Hospira Inc., A Pfizer Company
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.
| Date | Jul 28, 2016 |
| Status | Terminated |
| Reason | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units. |
| Root cause | Software design |
| Action | Hospira sent an Urgent Medical Device Correction letter dated July 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter provided instructions for step-by-step process to mitigate the issue. Customers with questions were instructed to contact Hospira Global Complaint Management at 1-800-441-4100 or Hospira Technical Service Center at 1-800-241-4002, option 4. |
| Quantity | 20 |
| Distribution | Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE Hospira, Inc., Jul 8, 2014 |