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).
This recall has been terminated (originally issued January 28, 2022).
- Company
- B Braun Medical Inc
- Recall Initiated
- January 28, 2022
- Terminated
- May 15, 2024
- Recall Number
- Z-0872-2022
- Quantity
- 80
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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
US Nationwide distribution.
Lot / Code Info
Lots 4/21 and 5/21
Root Cause
Process control
Action Taken
On February 17, 2022, the firm, B.Braun Medical Inc., mailed out Recall Customer Notification Letters to affected consignees. Distributors should notify affected customers. Customers should identify any affected products within the spare parts inventory of their facility, cease use, and quarantine the product. Do not destroy any affected product. If any machine exhibited repeated Alarm Code 1026 - "UF balance? Air leakage in dialyzer coupling" alarms, customer should discontinue therapy on the device and immediately quarantine the machine until it can be inspected and any impacted sensors replaced. Customers should inspect ALL Dialog+ and Dialog+ Evolution dialysis machines in their facility which may have been serviced with potentially impacted sensors. Once the firm receives the customer acknowledgement form, a representative will contact the customer on how to return impacted sensors and/or to schedule a time to inspect equipment. Customers with questions should contact B. Braun Avitum Technical Services at 1-800-21-0445.