FDA-Device2018-08-22Class II
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
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.
Sold states
US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.
Affected count
74 pouches
Manufactured in
Avenida Cuarzo 250, Ensenada, Ejido Maneadero, Mexico
Products
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2804-2018Don't want to check this manually?
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