B. Braun Medical, Inc.: FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers.

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Singapore. Quantity: 24,400 units Lot/code info: UDI-DI: 4022495769558 Lots 0061755752, 0061761812, 0061766279

UPC codes

4022495769558

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.