ICU Medical de Mexico, S.A. de C.V.: Medical Device Recall in 2018 - (Recall #: Z-2801-2018)

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:

216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.

Product Classification:

Class II

Date Initiated: March 1, 2018

Date Posted: August 22, 2018

Recall Number: Z-2801-2018

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: 50 pouches

Code Information:

Item Number 011-AM3010. Lot Number 3424312, UDI Number (01) 1 0840619 09487 1 (17) 220301 (30) 50 (10) 3424312, Expiration Date 03/01/2022

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated