icumedical ChemoClave Vented Vial Spike — Class I medical device recall Z-1092-2019
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-1092-2019 |
|---|---|
| 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 | 27,200 devices |
| Reason classes | specification failure |
| Lot numbers | 3866759, 3872252, 3910046, 3910627 |
| Model numbers | CH-70S |
Product
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
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-1092-2019. 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.