icumedical ChemoLock — Class I medical device recall Z-1096-2019
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-1096-2019 |
|---|---|
| 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 | 160,775 devices |
| Reason classes | specification failure |
| Lot numbers | 3820519, 3820522, 3824204, 3824209, 3826652, 3828646, 3829557, 3836196, 3836811, 3839240, 3839241, 3844783, 3844784, 3853995, 3853997, 3854004, 3854005, 3866764, 3866766, 3872065, 3872072, 3872085, 3872093, 3872433, 3872444, 3910642, 3910656, 3920773, 3932270, 3932907, 3945868, 3946771, 3946772, 3946776 |
| Model numbers | 80S, CL-80S, CL-80S-10 |
Product
icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
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-1096-2019. 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.