B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk
B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.
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 is an FDA Class II medical device recall involving a risk-of-harm product. The source describes potential for serious complications including medication underdosing and bloodstream infections, but does not report any confirmed illnesses or injuries, limiting the score to 3 per the rubric.
Plain-English summary
B. Braun Medical, Inc. is recalling 978,876 units of single-use infusion pump sets (Material ID 354212) designed for use with Outlook Safety Infusion Systems and Horizon NXT Pumps. The sets deliver parenteral fluids and medications to patients.
The pump sets can leak in the cassette portion. This leakage may prevent proper medication delivery, causing delays in medication administration, under-delivery or incomplete dosing, and potentially creating a risk of bloodstream infections.
The recalled products are distributed worldwide, including throughout the United States and Canada. Multiple lot codes are included in this recall.
Healthcare facilities and patients should verify the lot code on their pump sets against the recalled lot numbers and contact B. Braun Medical, Inc. for information about this recall and replacement options.
The recalled product
- Product
- 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 978,876
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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