Nimbus Administration Set — Class II medical device recall Z-2055-2019
Terminated recall by InfuTronix LLC, reported 2019-07-31. Potential for tube leakage
| Recall number | Z-2055-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InfuTronix LLC, Natick, MA, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-06-22 |
| Quantity | 10,800 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00817170020031 |
| Lot numbers | 1710012, 1712005, 1805002, 1901003 |
| Model numbers | HS-004 |
| Expiration dates | 2020-10-22, 2020-12-19, 2021-06-10, 2022-01-07 |
Product
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Reason for recall
Potential for tube leakage
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-2055-2019. 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.