Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
FDA device recall Z-0837-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- B Braun Medical, Inc
- Reason for recall
- 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.
- Action taken
- B. Braun Medical Inc. notified consignee by letter on August 24, 2010.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2,107 Pumps (582 Pumps to Winchester)
- Distribution
- Virginia and New York
- Date initiated
- 2010-08-24
- Date posted
- 2011-01-10
- Date terminated
- 2014-05-29
- Location
- Carrollton, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON OUTLOOK WITH DOSECOM (K011975) | B.Braun Medical, Inc. | 2001-09-19 |
| HORIZON LIGHT (K994375) | B.Braun Medical, Inc. | 2000-03-08 |