—#144856

Product

Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 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 product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K083460, K963440
Affected lot / code info: Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.

Why it was recalled

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2016-04-01
Posted by FDA: 2016-05-03
Terminated: 2017-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.