ICU Medical de Mexico, S.A. de C.V.: Medical Device Recall in 2018 - (Recall #: Z-2804-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.

Product Classification:

Class II

Date Initiated: March 1, 2018

Date Posted: August 22, 2018

Recall Number: Z-2804-2018

Event ID: 80460

Reason for Recall:

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.

Status: Terminated

Product Quantity: 74 pouches

Code Information:

Item Number 011-AM6116. a. Lot Number 3380551, UDI Number (01) 1 0840619 09274 7 (17) 211201 (30) 50 (10) 3380551, Expiration Date 12/01/2021; b. Lot Number 3493462, UDI Number (01) 1 0840619 09274 7 (17) 220701 (30) 50 (10) 3493482, Expiration Date 07/01/2022

Distribution Pattern:

US distribution to AZ, MA, NC, OH, TX, VA, WA. Worldwide distribution to Belgium, France, Germany.

Voluntary or Mandated:

Voluntary: Firm initiated