Z-0352-2026 Class II Ongoing

Recalled by ICU Medical, Inc. — San Clemente, CA

Recall Details

Product Type
Devices
Report Date
November 5, 2025
Initiation Date
September 8, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1700 units

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.

Distribution Pattern

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.

Code Information

UDI:10887709071411/Lot:14391954