Z-0347-2026 Class II Ongoing
FDA device recall Z-0347-2026 was initiated by ICU Medical, Inc. on Sep 8, 2025 and is designated Class II. Reason for recall: Port weld of drug transfer device may separate or break during use and potentially result in a leak. The recall status is ongoing. Affected quantity: 53,050 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2025
- Initiation Date
- Sep 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,050 units
Product Description
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
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:10887709069593/Lot:14379182, 14391979, 14395300, 14401254, 14380121