CLASS I Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Outlook ES pump is intended for use with B recalled by B Braun Medical

B Braun Medical is recalling Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets, distributed nationwide in the US. The recall was initiated on 14 Nov 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel number: 621-300ES and 621-400ES. Multiple serial numbers affected.

Quantity recalled6,919

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2188-2013
FDA event ID: 64152
Recalling firm: B Braun Medical, Carrollton, TX
Classification: Class I
Status: Terminated
Recall initiated: 14 Nov 2012
FDA classified: 13 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

14 Nov 2012	Recall initiated by company
13 Sep 2013	Classified by FDA	+303 days
25 Sep 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.

Nationwide Arkansas California Florida Illinois Louisiana Maryland Maine Minnesota North Carolina New Jersey New York South Carolina Tennessee Texas Virginia Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.

Where was it sold?

Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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