Events

Recall of FlexTray"Procedure Delivery System ENDOPATH

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
    48604
  • Event Risk Class
    Class 2
  • Event Number
    Z-2164-2008
  • Event Initiated Date
    2008-04-24
  • Event Date Posted
    2008-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71720
  • 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
    Convenience Kits - Product Code FZT
  • Reason
    The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
  • Action
    Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.

Device

FlexTray"Procedure Delivery System ENDOPATH
  • Model / Serial
    Batch #: D4GR6F, D4GR6P, D4GT7G, D4H14H; Product Code: FD064, Batch # D4G520; Product Code: FDB15, Batch # D4GD04; Product Code: TGL45XL, Batch # D4J493; Product Code: XBB02B, Batch # D4GK74, D4GU1T, D4HL3X, D4HL7C, D4HM4P, D4HM9D, D4JE0R; Product Code: XBB58S, Batch # D4G94G, D4GK69, D4GP93, D4GW31, D4HG6V, D4J204; Product Code: XBB59S, Batch # D4GA1K, D4GC1G, D4GD9U, D4GD7C, D4GX8R, D4HD17, D4HD6X, D4HE54, D4HM6G; Product Code: XLB01B, Batch # D4GD0R, D4GF8J, D4H593, D4HR87; Product Code: XLB50S, Batch # D4GK4X, D4GP94, D4GT3K, D4HF0V, D4J47E, D4JE8P; Product Code: XPD51S, Batch # D4GT7T, D4HF7M , D4J32T
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
  • Product Description
    FlexTray"Procedure Delivery System ENDOPATH¿; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. || Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

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