Z-0873-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- January 28, 2022
- Termination Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95
Product Description
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. 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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lots 4/21 and 5/21