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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
FDA Enforcement
Class II
·Terminated·LivaNova USA·May 30, 2018
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015