Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage
B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.
What this means for you
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 of a medical device with significant potential hazards including bloodstream infection risk and medication exposure to healthcare workers and patients. However, no illnesses or injuries have been reported in the source text, placing it in the 'High' category per the rubric's criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling approximately 350 units of the 30 ML 2PORT Burette Assembly (Article No. 7A3950, Lot 0061766049) used in contrast management systems. The devices were distributed worldwide, including throughout the United States, Canada, and Singapore.
The recalled devices may leak as a result of a manufacturing issue. Potential leakage may delay medical therapy, increase the risk of bloodstream infection (BSI), and expose both patients and healthcare workers to hazardous medication. There is potential for life-threatening situations that may require additional medical intervention.
Healthcare facilities should immediately identify and isolate units from Lot 0061766049 and contact B. Braun Medical for replacement or return instructions.
The recalled product
- Product
- 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- leakage
- bloodstream-infection
- medication-exposure
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)
- UDI-DI: N/A Lots 0061766049
Distribution
Distributed nationwide across the United States.
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