Class I — 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 I |
| Status | Terminated |
| Reason | There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device. |
| Product | icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications. |
| Quantity | 300 devices |
| Distribution | Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore. |
| Initiated | 2019-02-21 |
| Classified | 2019-04-15 |
| Terminated | 2024-06-04 |
| Recall number | Z-1095-2019 |
| 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 I recall — ICU Medical, Inc. (Z-1095-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82291/
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