ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System… — Class II medical device recall Z-0652-2025
Ongoing recall by ICU Medical, Inc., reported 2024-12-18, distributed nationwide. Due to finished goods incorrectly packaged and labeled.
| Recall number | Z-0652-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2024-12-09 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6,000 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10887709057125 |
| Lot numbers | 13959938 |
| Model numbers | CL-80 |
Product
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
Reason for recall
Due to finished goods incorrectly packaged and labeled.
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-0652-2025. 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.