icumedical ChemoLock Vial Spike — Class I medical device recall Z-0805-2019
Terminated recall by ICU Medical, Inc., reported 2019-03-06, distributed in CA, FL, IA, IL, OH, PA, VA. There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
| Recall number | Z-0805-2019 |
|---|---|
| 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 | 2019-01-03 |
| Classified | 2019-02-22 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2024-05-29 |
| Distributed | CA, FL, IA, IL, OH, PA, VA |
| Countries outside the US | AT, CN, IE, IT, SG, TW |
| Quantity | 2,050 units |
| Reason classes | specification failure |
| Lot numbers | 3757712 |
| Model numbers | CL-80S |
Product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S 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.
Reason for recall
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
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-0805-2019. 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.