ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0364-2026
Product Description
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Reason for Recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 134,700 units
- Distribution
- 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.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
ICU Medical ChemosafeLock Connecter REF: KL-FNU3. Recalled by ICU Medical, Inc.. Units affected: 134,700 units.
Why was this product recalled? ▼
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0364-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11