FDA-Device2018-08-22Class II
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
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
302 pouches
Manufactured in
Avenida Cuarzo 250, Ensenada, Ejido Maneadero, Mexico
Products
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2806-2018Don't want to check this manually?
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