FDA-Device2025-11-05Class II
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
ICU Medical, Inc.
Hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sold states
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.
Affected count
2100 units
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0329-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief