Events

Recall of Device Recall SCIPRO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Scion Cardio-Vascular, 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
    27452
  • Event Risk Class
    Class 2
  • Event Number
    Z-0557-04
  • Event Initiated Date
    2003-06-30
  • Event Date Posted
    2004-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29901
  • 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
    Dislodger, Stone, Flexible - Product Code FGO
  • Reason
    The firm received field complaints that it was difficult to open the stone retrieval basket during use.
  • Action
    The firm mailed a recall letter to there consignees on June 30, 2003 requesting return of any unused devices. The firm has received 100% response and accounted for all recalled devices.

Device

Device Recall SCIPRO
  • Model / Serial
    Lot Number OML30522-01
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The software systems were installed at 2 medical centers in Illinois and Alabama.
  • Product Description
    The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.
  • Manufacturer
    Scion Cardio-Vascular, Inc.

Manufacturer

Scion Cardio-Vascular, Inc.
  • Manufacturer Address
    Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami FL 33186
  • Source
    USFDA