medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, C

Recalled Product

43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, 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

Affected States: AZ, MA, NC, OH, TX, VA, WA
Lot/Code Info: Item Number 011-AM3011. Lot Number 3408988, UDI Number (01) 1 0840619 09531 1 (17) 220201 (30) 50 (10) 3408988, Expiration Date 02/01/2022
View official government recall

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