medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave

Recalled Product

PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), 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-AM6118. a. Lot Number 3358780, UDI Number (01)01 0840619 09319 (17) 211101 (30) 50 (10) 3358780, Expiration Date 11/01/2021; b. Lot Number 3365174, UDI Number (01) 01 0840619 09319 5 (17) 211101 (30)50 (10) 3365174, Expiration Date 11/01/2021; c. Lot Number 3367857, UDI Number (01) 01 0840619 09319 8 (17) 211101 (30) 01 (10) 3387857, Expiration Date 11/01/2021; d. Lot Number 3497708, UDI Number (01) 1 0840619 09319 5 (17) 220701 (30) 50 (10) 3497708, Expiration Date 07/01/2022; e. Lot Number 3508531, UDI Number (01) 1 0840619 09319 5 (17) 220801 (30) 50 (10) 3508531, Expiration Date 08/01/2022

View official government recall

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