The Recall Desk
SevereFDA (Devices)·Z-2188-2013·Announced 2013-09-25

B. Braun Outlook ES Infusion Pumps Recalled for Display Error

B. Braun Medical Inc. is recalling Outlook ES pumps because the display may show infusion is active when the pump has actually stopped.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

B. Braun Medical Inc. is recalling 6,919 Outlook ES Safety Infusion Systems (models 621-300ES and 621-400ES). The recall is a follow-up to a field correction initiated on August 26, 2011.

The affected pumps may halt the infusion of fluids while the "RUN" light-emitting diodes (LEDs) on the front display continue to advance, giving the false impression that the pump is still infusing. Although the pump emits a backup alarm, there are no visual indicators on the display that the infusion has stopped.

The products were distributed nationwide in the United States, including in Arkansas, California, Florida, Illinois, Louisiana, North Carolina, New Jersey, New York, Maryland, Maine, Minnesota, South Carolina, Tennessee, Texas, Virginia, Wisconsin, and West Virginia. Users should contact B. Braun Medical Inc. for instructions on how to address the issue.

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 con
Manufacturer
B Braun Medical, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
6,919

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 (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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