Events

Recall of Device Recall Echelon Flex Powered Vascular Stapler With Advanced Placement Tip and White Reloads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery 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
    71215
  • Event Risk Class
    Class 2
  • Event Number
    Z-1641-2015
  • Event Initiated Date
    2015-02-26
  • Event Date Posted
    2015-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136653
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.
  • Action
    Ethicon sent an Urgent Medical Device Recall letter dated February 27, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine your inventory immediately to determine if you have recalled product on hand, remove and quarantine the recalled product, communicate the issue to relevant operating room or materials management personnel or anyone else in your facility who needs to be informed, if any product included in this recall has been forwarded to another facility, contact that facility to arrange return, and complete the Business Reply Form (BRF) (Attachment B) confirming receipt of this notice within three (3) business days. The BRF may be sent to Stericycle by fax at 1-800-807-5967or by email at ees8760@stericycle.com. Please return the BRF even if you do not have affected product. For clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266) (7:30 a.m.  6:30 p.m. EST). If you need additional shipping labels or a communications package, contact Stericycle at 1-877-643-8419 (8:00 a.m.  5:00 p.m. EST) and reference Event 8760.

Device

Device Recall Echelon Flex Powered Vascular Stapler With Advanced Placement Tip and White Reloads
  • Model / Serial
    M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
  • Product Description
    ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, || Product Usage: || The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA