ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202
Pending LLM rewrite. Source: FDA_DEVICE Z-0365-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
The recalled product
- Product
- ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367
- KL-VA002U3: 14345872
- KL-VA131U3: 14381373
- KL-VA201U3: 14337455 14381355 14381358
- KL-VA202U3: 14367718
- KL-VA321U3: 14345878
- Distributed in Japan
Distribution
Distributed nationwide across the United States.
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