Recall Z-0837-2011 ยท FRN Pump, Infusion
B Braun Medical, Inc
Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
| Date | Jan 10, 2011 (initiated Aug 24, 2010) |
| Status | Terminated |
| Reason | Possible pump stop with audible alarm, but no visual error indication that the pump is not delivering the medication. Under certain conditions in a network environment, Management Processor may become non-responsive, ceasing normal operation. |
| Root cause | Component design/selection |
| Action | B. Braun Medical Inc. notified consignee by letter on August 24, 2010. |
| Quantity | 2,107 Pumps (582 Pumps to Winchester) |
| Distribution | Virginia and New York |
| FDA record | Open on fda.gov |