FDAHealthSeptember 8, 2025
ICU Medical, Inc. — ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
⚠️ 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 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
- Brand
- ICU Medical, Inc.
- Lot code
- 14332784
Additional details
UDI:10887709123356/Lot: 14332784
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 200 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.