PlainRecalls
FDA Devices Moderate Class II Ongoing

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0352-2026

Product Description

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

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
1700 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 Graduated Connector w/ChemoLock Port REF: CL3900. Recalled by ICU Medical, Inc.. Units affected: 1700 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-0352-2026.