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Terminated

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

FDA Recall Z-1536-2016 · Posted 2016-05-03

Recalling FirmB Braun Medical Inc
Recall StatusTerminated
Product CodeKDI
Date Initiated2016-04-01
Date Terminated2017-07-11
Product Quantity147

Reason for Recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Firm Action

B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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