Events

Recall of Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw,

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
    61314
  • Event Risk Class
    Class 2
  • Event Number
    Z-1244-2012
  • Event Initiated Date
    2012-01-26
  • Event Date Posted
    2012-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107789
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Ethicon endo-surgery initiated a voluntary global recall for specific production lots of enseal¿ g2 curved and straight tissue sealers due to two potential issues that may occur related to the activation button: (i) continuous activation: the enseal¿ device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) no activation.
  • Action
    Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales representative Call 1-800-873-3636, Option 6 Fax the BRF to 1-513-337-4138 For any questions regarding this recall call 513-337-3419.

Device

Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw,
  • Model / Serial
    Product Code 00NSLG2C14, Lot # H44Y2P, Exp Date Nov-2013; Product Code 00NSLG2C25, Lot # H44Z6V, Exp Date Nov-2013 & Lot # J4A16C, Exp Date Dec-2013
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • Product Description
    ENSEAL¿ 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL¿ 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw, Model # NSLG2C25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • 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