BEUDAMED
    FDA Enforcement Class II Terminated

    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

    Recall: Z-1772-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1772-2013
    Event ID
    65504
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon Endo-Surgery Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    April 8, 2013
    Classification Date
    July 19, 2013
    Termination Date
    December 24, 2013
    Address
    4545 Creek Rd, N/A, Cincinnati, OH, 45242-2803, United States

    Description

    Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.

    Reason

    The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.

    Code Info

    Product Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.

    Quantity

    327,648 instruments