Events

Recall of Device Recall EBI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EBI, L.P..

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
    26512
  • Event Risk Class
    Class 2
  • Event Number
    Z-1006-03
  • Event Initiated Date
    2003-06-17
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27812
  • 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
    Endoscope, Neurological - Product Code GWG
  • Reason
    Non sterile device is labeled sterile.
  • Action
    The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.

Device

Device Recall EBI
  • Model / Serial
    Catalog Number: S002 Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019, F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005, F10003, F10016, F10015, F10002, F10027.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals, clinics, and doctors nationwide.
  • Product Description
    EBI VueCath Endoscopic Spinal System
  • Manufacturer
    EBI, L.P.

Manufacturer

EBI, L.P.
  • Manufacturer Address
    EBI, L.P., 100 Interpace Parkway, Parsippany NJ 07054-1079
  • Source
    USFDA