ICU Medical de Mexico, S.A. de C.V.: Medical Device Recall in 2018 - (Recall #: Z-2810-2018)

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:

38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.

Product Classification:

Class II

Date Initiated: March 1, 2018

Date Posted: August 22, 2018

Recall Number: Z-2810-2018

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: 350 pouches

Code Information:

Item Number 011-AM6132. a. Lot Number 3484175, UDI Number (01) 1 0840619 09743 6 (17) 220601 (30) 50 (10) 3484175, Expiration Date 07/01/2022; b. Lot Number 3493946, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3493946, Expiration Date 07/01/2022; c. Lot Number 3498103, UDI Number (01) 1 0840619 09743 6 (17) 220701 (30) 50 (10) 3498103, 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