FDA-Device2025-11-05Class II
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
ICU Medical, Inc.
Hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sold states
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.
Affected count
1100 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0334-2026Don't want to check this manually?
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