Events

Recall of Device Recall The EBB Complete Tamponade System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clinical Innovations, LLC.

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
    72018
  • Event Risk Class
    Class 2
  • Event Number
    Z-0123-2016
  • Event Initiated Date
    2015-01-05
  • Event Date Posted
    2015-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139610
  • 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
    Intrauterine tamponade balloon - Product Code OQY
  • Reason
    Clinical innovations, llc is voluntarily recalling the ebb complete tamponade system (cts-1000) lot number 1214-f-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.
  • Action
    Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.

Device

Device Recall The EBB Complete Tamponade System
  • Model / Serial
    Manufacturing lot 1214-F-403 and 1214-V-424
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.
  • Product Description
    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. || Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
  • Manufacturer
    Clinical Innovations, LLC

Manufacturer

Clinical Innovations, LLC
  • Manufacturer Address
    Clinical Innovations, LLC, 747 W 4170 S, Murray UT 84123-1364
  • Manufacturer Parent Company (2017)
    Eqt Partners Ag
  • Source
    USFDA