US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water… — Class II medical device recall Z-2141-2024
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2024-06-19, distributed nationwide. Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between
| Recall number | Z-2141-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2024-05-16 |
| Classified | 2024-06-13 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 04251285200357 |
| Serial numbers | 2AAV0003, 2AAV0029, 2AAV0037, 3AAV0087 |
| Model numbers | 24-090A-1, G02020110 |
Product
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Reason for recall
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
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-2141-2024. 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.