Reported Nov 5, 2025 · Ongoing
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
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 ChemosafeLock Vial Adapter REFsKL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- Lot codes and dates
- LotKL-VA001U3: 14360690 14345871 14367719 14381368 14381367
- KL-VA002U314345872
- KL-VA131U314381373
- KL-VA201U314337455 14381355 14381358
- KL-VA202U314367718
- KL-VA321U314345878 ; Distributed in Japan
- Amount recalled
- 202900 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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