Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw

  • Model / Serial
    Product Code 00NSLG2S14, Lot #, H44Z5R, Exp Date, Nov-2013; Product Code 00NSLG2S25, Lot #, H44Z57, Exp Date, Nov-2013 & Lot # J4A28X, Exp Date, Dec-2013
  • Product Classification
  • Device Class
    Unclassified
  • 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 Straight Jaw, Model # NSLG2S14 and ENSEAL¿ 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. 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
  • 1 Event

Manufacturer

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