Events

Recall of Device Recall Better Baldder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Circulatory Technology Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74614
  • Event Risk Class
    Class 3
  • Event Number
    Z-0057-2017
  • Event Initiated Date
    2016-07-01
  • Event Date Posted
    2016-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148047
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • Reason
    Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
  • Action
    The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to ytamari@cirtec.com. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.

Device

Device Recall Better Baldder
  • Model / Serial
    Lot Numbers: R19229, 015323, 014882, 014602 & 014601
  • Product Classification
    Cardiovascular Devices
  • 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
    Circulatory Technology Inc

Manufacturer

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