Prometra II Programmable 20mL Pump — Class II medical device recall Z-1125-2020
Ongoing recall by Flowonix Medical Inc, reported 2020-02-19, distributed nationwide. A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error
| Recall number | Z-1125-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flowonix Medical Inc, Mansfield, MA, United States |
| Recall initiated | 2019-12-24 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, GB, GR, IE, IT, NL, PL |
| Quantity | 1,083 |
| Reason classes | software |
| Model numbers | 93827 |
Product
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
Reason for recall
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
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-1125-2020. 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.