FDAHealthSeptember 8, 2025
ICU Medical, Inc. — ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
⚠️ Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 8, 2025
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.
What's affected?
- Product
- ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
- Brand
- ICU Medical, Inc.
- Lot code
- 14386054
Additional details
UDI:10887709057019/Lot: 14386054
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11000 units.
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