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ICU Medical de Mexico, S.A. de C.V. recalls 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, steril
Recalled August 22, 2018 · FDA recall Z-2799-2018 · ICU Medical de Mexico, S.A. de C.V
Hazard
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. · FDA Class II
Units
100 pouches
Sold at
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Description
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.
Product
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 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.
Manufacturer(s)
ICU Medical de Mexico, S.A. de C.V.
Made in
Mexico
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →