Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Reason for recall: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process. Distribution: Worldwide - US Nationwide and the countries of Canada. Quantity: 651,789 Lot/code info: UDI-DI 10888277314719 (ea) 40888277314710(case) All Lots
10888277314719, 40888277314710
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.