ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike
- Recalling company
- ICU Medical, Inc.
- Product
- ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
- Reason
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 8, 2025
- Reported
- Nov 5, 2025
- 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.
- Status
- Ongoing
- Quantity
- 80 units
- Lot / codes
- Lot:14401659/ Distributed in France
- Company location
- San Clemente, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0354-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0354-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.