Device product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Z-0365-2026
Product summary
- Event
- Event 97583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 202900 units
- Official record key
device-enforcement:Z-0365-2026
Official wording
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code information: 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 pattern: 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.
Derived failure modes
-
Unknown
Port weld of drug transfer device may separate or break during use and potentially result in a leak.