Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis… — Class II medical device recall Z-0872-2022
Terminated recall by B Braun Medical Inc, reported 2022-04-20, distributed nationwide. Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a l
| Recall number | Z-0872-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2022-01-28 |
| Classified | 2022-04-14 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 80 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04046963686338, 04046963686345, 04046964285608, 04046964285615 |
| Lot numbers | 4/21, 5/21 |
Product
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
Reason for recall
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
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-0872-2022. 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.