ICU Medical, Inc. — ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
⚠️ Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 8, 2025
Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
What's affected?
- Product
- ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
- Brand
- ICU Medical, Inc.
- Lot code
- KL-VA001U3:
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 202900 units.
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