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.
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: 12,800 units Lot/code info: UDI-DI: N/A Lots 0061753485
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.