Device product
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Z-0338-2026
Product summary
- Event
- Event 97583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 950 units
- Official record key
device-enforcement:Z-0338-2026
Official wording
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code information: UDI:10887709098388/Lot: 14400230
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.