PlainRecalls
FDA Devices Moderate Class II Ongoing

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0365-2026

Product Description

ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

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
202900 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 Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3. Recalled by ICU Medical, Inc.. Units affected: 202900 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-0365-2026.