Z-2188-2013Class I

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

Name: Z-2188-2013 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: 2012-11-14
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2012-11-14 / 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 2012-11-14. FDA classified it as Class I and gives the reason as "This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN"...". 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-2188-2013
Classification: Class I
Status: Terminated
Initiated: 2012-11-14
Posted: 2013-09-13
Terminated: 2015-03-06
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: 621-300ES 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 August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm, but there are no visual indicators that the infusion
Root cause tag: software
FDA root cause: Software design
Action: The firm, B Braun Medical Inc, sent an "Urgent Expanded Medical Device Field Correction" letter dated November 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that pumps that have been upgraded (software version 151599 or higher), no additional action is required on their part at this time. For the pumps that have not yet been upgraded, within three weeks of the letter, customers should confirm the serial numbers using the enclosed response form or contact B. Braun Medical, Inc. Infusion Systems Customers Support at 1-800-627-7867 (800-627-PUMP) to schedule their upgrade. For questions regarding this recall call 972-245-2243.
Quantity in commerce: 6,919
Distribution: Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.
Product codes and lots: Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2188-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2013	Class I	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13

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)