Z-0837-2011

Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump...

Name: Z-0837-2011 Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump...
Creator: B Braun Medical, Inc
Published: 2010-08-24
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2010-08-24 / Terminated / root cause: design

FDA source

B Braun Medical, Inc began a recall of Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets on 2010-08-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0837-2011
Status: Terminated
Initiated: 2010-08-24
Posted: 2011-01-10
Terminated: 2014-05-29
Recalling firm: B Braun Medical Inc
Product: Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: B. Braun Medical Inc. notified consignee by letter on August 24, 2010.
Quantity in commerce: 2,107 Pumps (582 Pumps to Winchester)
Distribution: Virginia and New York
Product codes and lots: Model No. 621-400ES. Premarket Notifications K011975 and K994375. Device Listings D051037 and D051592.

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)