Events

Recall of Device Recall Clinical Innovations

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
    70137
  • Event Risk Class
    Class 2
  • Event Number
    Z-1014-2015
  • Event Initiated Date
    2014-12-30
  • Event Date Posted
    2015-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132298
  • 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
    Potential for a balloon leak in all lots of (cts-1000) manufactured since august 2014.
  • Action
    Clinical Innovations sent an "Urgent - Medical Device Recall" letter dated December 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They will be instructed to quarantine remaining product. A company representative will visit the hospital and retrieve the product in accordance to instructions detailed on the Representative Recall Reconciliation Instructions. The representative will reconcile the inventory on the Field Reconciliation Form and return the product to Clinical Innovations as indicated on the instructions. The address for the devices to be returned is included on the Representative Recall Reconciliation Instruct Clinical Innovations is working diligently to resolve this issue. In the meantime ,please quarantine any remaining product in your hospital. A company representative will contact you and make arrangements for the return of the product. Clinical Innovations will provide replacement product as soon as it becomes available. If you have any questions,call Clinical Innovations,at 1-(888)268-6222 or your service representative, as is the name of the Company Contact.

Device

Device Recall Clinical Innovations
  • Model / Serial
    Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.
  • Product Description
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
  • 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