Agency classClass IIOur severity:High FDA (Devices)·Z-2163-2013·Announced 2013-09-18

B. Braun Outlook ES Infusion Pumps Recalled for Key Panel Failure

B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (infusion pump) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

B. Braun Medical Inc. is recalling the Outlook ES Safety Infusion System, a medical device used to regulate the flow of primary and secondary fluids when positive pressure is required. The recall involves 28,427 units distributed nationwide. The affected models are 621-100ES, 621-200ES, 621-300ES, and 621-400ES.

The recall is due to a potential issue where the key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue specifically affects the HOLD button. If this failure occurs, the Door Processor (DP) will not receive the desired input from the user.

Healthcare facilities and users of these infusion pumps should contact B. Braun Medical Inc. for further instructions on how to address the issue with the key panel.

The recalled product

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…
Manufacturer: B Braun Medical, Inc.
Category: Medical Device — Infusion Pump
Hazard: electrical-failure
device-malfunction
Affected units: 28,427

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · B Braun Medical, Inc.

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