Z-2164-2013Class II

Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the...

Name: Z-2164-2013 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the...
Creator: B Braun Medical, Inc.
Published: 2012-10-31
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2012-10-31 / Terminated / root cause: software

FDA source

B Braun Medical, Inc. began a recall of Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive... on 2012-10-31. FDA classified it as Class II and gives the reason as "This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2164-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-31
Posted: 2013-09-06
Terminated: 2016-02-03
Recalling firm: B Braun Medical Inc
Product: Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
Product code: FRN Pump, Infusion
Reason for recall: This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
Root cause tag: software
FDA root cause: Software design
Action: The firm decided to conduct a field correction to correct the issue and carried it out through routine field services. The firm was notified by FDA that this is a reportable event, so they notified their consignees via letters dated 10/31/2012.
Quantity in commerce: 1,970 pumps added for this expansion
Distribution: Nationwide Distribution.
Product codes and lots: Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2164-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2164-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-06

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)