Ivenix Infusion System — Class II medical device recall Z-1381-2022
Terminated recall by Ivenix, Inc., reported 2022-07-20, distributed nationwide. Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
| Recall number | Z-1381-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivenix, Inc., North Andover, MA, United States |
| Recall initiated | 2022-04-22 |
| Classified | 2022-07-13 |
| Reported by FDA | 2022-07-20 |
| Terminated | 2024-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,335 devices |
| Reason classes | device malfunction |
| Serial numbers | 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300423, 2119300424, 2119300425, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437 and 475 more |
Product
Ivenix Infusion System (IIS)
Reason for recall
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
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-1381-2022. 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.