Device product
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Z-0334-2026
Product summary
- Event
- Event 97583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1100 units
- Official record key
device-enforcement:Z-0334-2026
Official wording
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code information: UDI:10887709076768/Lot: 14400216, 14416769
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.