Device product
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Z-0359-2026
Product summary
- Event
- Event 97583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11000 units
- Official record key
device-enforcement:Z-0359-2026
Official wording
Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Code information: Lot:14397353, 14418912; Distributed in Canada
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.