FDA Enforcement
Class II
Ongoing
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Recall: Z-0365-2026
·
Reported November 5, 2025
Enforcement
- Recall Number
- Z-0365-2026
- Event ID
- 97583
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ICU Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2025
- Initiation Date
- September 8, 2025
- Classification Date
- October 27, 2025
- Address
- 951 Calle Amanecer, N/A, San Clemente, CA, 92673-6212, United States
Description
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Reason
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code Info
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
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.
Quantity
202900 units