B. Braun Infusion Pump Sets Recalled Due to Cassette Leakage Risk
B. Braun Medical is recalling 1,960 infusion pump sets used with Outlook Safety and Horizon NXT systems due to leakage in the cassette portion, which may delay medication delivery and increase bloodstream infection risk.
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: This FDA Class II recall involves a medical device with potential for serious harm including bloodstream infections and medication dosing failures. No illnesses or injuries have been reported; the hazards are stated as theoretical. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,960 infusion pump sets designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. These single-use pump sets (Reference 354215) were distributed worldwide, including across the United States and Canada.
The infusion pump sets may experience leakage within the cassette portion, the component that interfaces with the pump system. This defect creates potential for delays in medication administration, under-delivery or incomplete dosing of prescribed treatments, and risk of bloodstream infections.
The recalled product
- Product
- 60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 1,960
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)
- Lot Code: 0061758630 0061763934 DI: 04046964182259
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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