—#192434

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).

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K083460
Affected lot / code info: Lots 4/21 and 5/21

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: B Braun Medical Inc
Address: 824 12th Ave, Bethlehem, Pennsylvania 18018-3524

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-01-28
Terminated: 2024-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.