medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold

Recalled Product

18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 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-AM6111. a. Lot Number 3442842, UDI Number (01) 1 0840619 08918 1 (17) 220501 (30) 50 (10) 3442842, Expiration Date 05/01/2021; b. Lot Number 3508246, UDI Number (01) 1 0840619 08918 1 (17) 220801 (30) 50 (10)3508246, Expiration Date 08/01/2022

View official government recall

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