medical Class II Updated 2018-08-22

ICU Medical de Mexico, S.A. de C.V. recalls 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, C

Recalled Product

61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.

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-AM6133. a. Lot Number 3493948, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3493948, Expiration Date 07/01/2022; b. Lot Number 3498107, UDI Number (01) 1 0840619 09744 5 (17) 220701 (30) 50 (10) 3498107, Expiration Date 07/01/2022

View official government recall

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