ICU Medical de Mexico, S.A. de C.V. recalls 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w
Recalled Product
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
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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