IV Fitting Components Recalled Due to Manufacturing Defect and Leakage Risk
B. Braun Medical is recalling 175,000 units of bulk largebore male LL fittings due to a manufacturing defect that may cause leakage, potentially increasing 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 with no reported illnesses, injuries, or deaths. Although the potential hazards—bloodstream infection risk and life-threatening complications—are serious, the lack of reported harm and the Class II classification place this in the High category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 175,000 units of bulk largebore male LL fittings (Article No. M4341750SN) used in IV administration systems. The affected lot numbers are 0061744741 and 0061749486.
The devices may leak as a result of a manufacturing defect. Leakage may delay therapy, increase the risk of bloodstream infection, and expose patients and healthcare workers to hazardous medications. There is also potential for life-threatening situations requiring additional medical intervention.
The products were distributed worldwide, including throughout the United States, Canada, and Singapore.
Patients and healthcare providers who have received these products should immediately discontinue use and contact B. Braun Medical, Inc. for instructions regarding replacement and proper handling.
The recalled product
- Product
- BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 175,000
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 (2)
- UDI-DI: N/A Lot 0061744741
- 0061749486
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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