ICU Medical, Inc.: ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ICU Medical, Inc.
- Product
- ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
- Reason / hazard
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-09-08
- Code info
- Lot:14369083 14386090 14391965; Distributed in Canada
- Product quantity
- 5700 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Clemente
- State
- CA
- Country
- United States
- Event id
- 97583
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