[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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