Events

Recall of Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery.

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
    27763
  • Event Risk Class
    Class 2
  • Event Number
    Z-0216-04
  • Event Initiated Date
    2003-11-25
  • Event Date Posted
    2003-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30576
  • 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
    Instrument, Ultrasonic Surgical - Product Code LFL
  • Reason
    A defective articulation band may result in improper staple formation with possible hematosis.
  • Action
    The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.

Device

Device Recall Kit containing Endopath ETSFlex Articulating Endoscopic Linear Cutter
  • Model / Serial
    Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals and distributors located nationwide and worldwide.
  • Product Description
    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery
  • Manufacturer Address
    Ethicon Endo-Surgery, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Source
    USFDA