Device Recall Diacap(R) Ultra Dialysis Fluid Filter

  • Modelo / Serial
    Lot numbers 302950410, 309910111, 313050411, 314300511, 316040711, 316450711, 305880812, 306301012, and 306311012.  This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.
  • Descripción del producto
    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. || Intended to filter bacteria and endotoxins from dialysis fluid.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA