Device product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Z-0353-2026
Product summary
- Event
- Event 97583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6450 units
- Official record key
device-enforcement:Z-0353-2026
Official wording
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code information: UDI:10887709071411/Lot:14386086 14407433
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.