Recall Z-0872-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
B Braun Medical Inc
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
| Date | Jan 28, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 re |
| Quantity | 80 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083460 | DIALOG WITH ADIMEA OPTION B. Braun Avitum AG, Feb 18, 2010 |