Z-2175-2013Class II

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

Name: Z-2175-2013 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: 2012-12-05
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2012-12-05 / Terminated / root cause: design

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 2012-12-05. FDA classified it as Class II and gives the reason as "B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods...". 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-2175-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-05
Posted: 2013-09-10
Terminated: 2014-10-24
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, and 621-200ES. 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: B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, B. Braun Medical Inc., sent an "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter dated December 05, 2012 to its customers. The letter describes the product, problem and actions taken. The firm finished performing "field upgrades" on March 20, 2010 for this issue. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Infusion Systems Customer Service at 1-800-627-7867 (627-PUMP).
Quantity in commerce: 14,161
Distribution: Worldwide Disribution: USA (nationwide) and country of: Canada.
Product codes and lots: Models 620-100 and 620-200; multiple serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2175-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2175-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-10

Product code FRN

K994375Class IIHorizon LightB.Braun Medical, Inc. / cleared 2000-03-08

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)