B. Braun Medical is recalling approximately 262,837 units of various fluid transfer sets, administration kits, and burette assemblies due to a manufacturing issue that can cause the devices to leak. These leaks can lead to a delay in critical medical therapy, increase the risk of bloodstream infections, and expose both patients and healthcare workers to hazardous medications. The affected products include various models such as the FT1000S Fluid Transfer Set and the SA3000 Vented Micro Spike Adapter, which were distributed worldwide including across the United States. Consumers and healthcare providers should check their inventory for specific lot numbers and contact the manufacturer for further instructions.
A manufacturing defect in the device components can cause fluid leakage during use. This may result in life-threatening situations due to therapy delays, potentially fatal bloodstream infections, or accidental exposure to hazardous drugs being administered through the sets.
Medical Device Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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