Class II — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Product | ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 |
| Quantity | 4000 units |
| 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. |
| Initiated | 2025-09-08 |
| Classified | 2025-10-27 |
| Recall number | Z-0342-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ICU Medical, Inc. (Z-0342-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97583/
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