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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- B Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- 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
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