Reported Nov 5, 2025 · Ongoing

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

ICU Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

  • ICU Medical ChemoLock
  • Bag Spike with Clave Additive Port REFCL3940
Lot codes and dates
  • UDI10887709095295/Lot: 14406773
Amount recalled
3000 units

This recall covers 38 products

The agency filed one notice per product. You are reading one of them; the other 37 are below.

25 more are in the archive.

Where it was sold

Why it was recalled

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.