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 | Terminated |
| Reason | Due to the incorrect filter assembly. |
| Product | 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). |
| Quantity | Total Kits = 7,500 for all four lots |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium. |
| Initiated | 2020-12-02 |
| Classified | 2021-02-05 |
| Terminated | 2023-06-30 |
| Recall number | Z-0955-2021 |
| 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-0955-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86973/
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