Events

Recall of Device Recall BBB38

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
    73608
  • Event Risk Class
    Class 2
  • Event Number
    Z-2050-2016
  • Event Initiated Date
    2016-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144568
  • 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
    The seal between the balloon and the housing may leak.
  • Action
    Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.

Device

Device Recall BBB38
  • Model / Serial
    Lot # 014603 USE BY: 9/2018
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
  • Product Description
    Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
  • 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