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B. Braun Medical, Inc. recalls FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution conta
Recalled November 15, 2023 · FDA recall Z-0128-2024 · B. Braun Medical
Hazard
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention. · FDA Class II
Units
24,400 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Description
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Product
FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.
Manufacturer(s)
B. Braun Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →