ICU Medical de Mexico, S.A. de C.V. recalls 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifo
Recalled Product
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Hazard / Issue
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Issued by
FDA
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