B Braun Medical Inc Recall 89784
Description: 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).
B Braun Medical Inc Recall 89784 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0872-2022 |
| Event ID | 89784 |
| Event Description | 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). |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 80 |
| Recall Reason | 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. |
| Device Classification | 20220420 |
| Device Code Info | Lots 4/21 and 5/21 |
| Center Classification Date | 20220414 |
| Recall Initiation Date | 20220128 |
| Recalling Firm | B Braun Medical Inc |
| Initial Notification | Letter |
| Similar To |