Device Recall Reprocessed Ethicon Xcel Trocar Sleeve

  • Modèle / numéro de série
    Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
  • Description du dispositif
    Stryker || Sustainability Solutions || CB5LT || Ethicon Endo-Surgery, Inc. || Excel Trocar Sleeve || w/Stability Sleeve || 5mm x 100mm || Reprocessed by Stryker Sustainability Solutions || Product Usage: || The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Sustainability Solutions, 1810 W Drake Dr, Tempe AZ 85283-4327
  • Société-mère du fabricant (2017)
  • Source
    USFDA