medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold

Recalled Product

11" Smallbore Ext Set w/NanoClave, 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 AM6127. a. Lot Number 3379607, UDI Number (01) 1 0887709 08635 4 (17) 211201 (30) 50 (10) 3379607, Expiration Date 12/01/2021; b. Lot Number 3436226, UDI Number (01) 1 0887709 08635 4 (17) 220401 (30) 50 (10) 3436226, Expiration Date 04/01/2022

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