ICU Medical, Inc.: ICU Medical ChemosafeLock Connecter REF: KL-FNU3
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 ChemosafeLock Connecter REF: KL-FNU3
- 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:14399518, 14399521, 14406408, 14399520, 14406410, 14406411 ; Distributed in Japan
- Product quantity
- 134,700 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Clemente
- State
- CA
- Country
- United States
- Event id
- 97583
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