Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold Recalled by ICU Medical de Mexico, S.A. de C.V. Due to ICU Medical is expanding the scope of their...
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
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
Quantity: 122 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
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.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report