B. Braun Outlook Pump Sets recalled for potential leakage and infection risk
B. Braun is recalling 585,576 Outlook Pump Sets due to potential leakage in the cassette portion. The defect may cause medication under-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 is an FDA Class II recall for a medical device with potential for serious harm. While no illnesses or infections have been reported, the defect creates risk for medication under-delivery and bloodstream infections, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling Outlook Pump Sets with 3 CARESITE Needle-Free Injection Sites (Material ID: 352413) used with the Outlook Safety Infusion System and Horizon NXT Pump. A total of 585,576 units are affected worldwide, including distribution in the United States and Canada.
The pump sets may leak within the cassette portion of the device. This leakage can delay medication administration and cause under-delivery or incomplete dosing of prescribed parenteral fluids. Additionally, the defect increases the risk of bloodstream infections.
Patients and healthcare providers using these devices should immediately stop use and contact B. Braun Medical, Inc. for replacement instructions. Affected lot codes are: 0061755638, 0061757839, 0061759426, 0061763839, 0061763893, 0061763894, 0061766190, 0061767014, 0061767027, 0061768466, 0061769094, 0061772192, 0061772193, 0061775455, 0061776025, 0061776298, 0061776299, 0061776300, 0061776301, 0061777154, 00VL752555, and 00VL754131 (Device Identifier: 04046964182211).
The recalled product
- Product
- Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 585,576
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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