CLASS II Device recall · Reported 18 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 24 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMultiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.

Quantity recalled28,427

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-2163-2013
FDA event ID: 64147
Recalling firm: B Braun Medical, Carrollton, TX
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2012
FDA classified: 6 Sep 2013
Reported: 18 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

24 Oct 2012	Recall initiated by company
6 Sep 2013	Classified by FDA	+317 days
18 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

B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels

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: 621-100ES, 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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.

Where was it sold?

Nationwide Distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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