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 | The connection between the Female Luer and the NanoClave® manifold has the potential for developing a leak. |
| Product | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave® Manifold, Check Valve, MicroClave® Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein). |
| Quantity | 120 units |
| Distribution | Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA. |
| Initiated | 2017-05-30 |
| Classified | 2017-07-11 |
| Terminated | 2024-09-20 |
| Recall number | Z-2717-2017 |
| 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-2717-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77560/
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