FDA recall Z-0359-2026

ICU Medical, Inc. · Class II · device

Product

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

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-0359-2026