BetterBladder

  • Model / Serial
    **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Product Description
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 9910-18907 (exp. 10/2011)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
  • Product Description
    The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
  • Manufacturer
  • Model / Serial
    **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
  • Product Description
    Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
  • Manufacturer