FDA recall Z-0338-2026

ICU Medical, Inc. · Class II · device

Product

ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

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.

Key facts

Status: Ongoing
Initiation date: 2025-09-08
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0338-2026