medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valv

Recalled Product

6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, 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 AM6130. a. Lot Number 3414534, UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534, Expiration Date 02/01/2022; b. Lot Number 3442461, UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461, Expiration Date 05/01/2022; b. Lot Number 3509517, UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517, Expiration Date 08/01/2022

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