Device Recall Better Baldder

  • Model / Serial
    Lot Numbers: R19229, 015323, 014882, 014602 & 014601
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
  • Product Description
    The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, || Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Circulatory Technology Inc, 21 Singworth St, Oyster Bay NY 11771-3703
  • Manufacturer Parent Company (2017)
  • Source
    USFDA