DOSI-FUSER 12591 5-500D1 -USA — Class II medical device recall Z-2360-2019
Terminated recall by Leventon S. A. U., reported 2019-09-04, distributed in AZ, CA, FL, MA, MI, PR. The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
| Recall number | Z-2360-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leventon S. A. U., Barcelona, N/A, Spain |
| Recall initiated | 2019-05-23 |
| Classified | 2019-08-23 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2020-06-08 |
| Distributed | AZ, CA, FL, MA, MI, PR |
| Quantity | 1,700 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08436020767470, 08436020768026 |
Product
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Reason for recall
The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
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-2360-2019. 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.