Z-0348-2026 Class II Ongoing
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
- 8475 units
Product Description
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
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:10887709077116/Lot:14395313, 14393195, 14396054