FDA-Device2017-07-19Class II
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..
ICU Medical, Inc.
Hazard
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Sold states
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Affected count
70 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)..
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2720-2017Don't want to check this manually?
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