Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

10" Smallbore Ext Set w/6-Port NanoClave Manifold Recalled by ICU Medical de Mexico, S.A. de C.V. Due to ICU Medical is expanding the scope of their...

Date: March 1, 2018
Company: ICU Medical de Mexico, S.A. de C.V.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical de Mexico, S.A. de C.V. directly.

Affected Products

10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer

Quantity: 650 pouches

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 7 states: AZ, MA, NC, OH, TX, VA, WA

Affected (7 states)Not affected

About ICU Medical de Mexico, S.A. de C.V.

ICU Medical de Mexico, S.A. de C.V. has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report