icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap — Class I medical device recall Z-1094-2019
Terminated recall by ICU Medical, Inc., reported 2019-04-24, distributed nationwide. There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate
| Recall number | Z-1094-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2019-02-21 |
| Classified | 2019-04-15 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2024-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, SG |
| Quantity | 18,150 devices |
| Reason classes | specification failure |
| Lot numbers | 3846114, 3855564, 3902719, 3961122 |
| Model numbers | 3943 |
Product
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1094-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.