medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold,

Recalled Product

DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.


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-AM3006. Lot Number 3508532, UDI Number (01) 1 0840619 09320 1 (17) 220601 (30) 20 (10) 3508532 , Expiration Date 08/01/2022
View official government recall

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