BEUDAMED
    FDA Enforcement Class II Terminated

    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

    Recall: Z-0798-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0798-2020
    Event ID
    84443
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    December 13, 2019
    Classification Date
    January 10, 2020
    Termination Date
    May 11, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

    Reason

    Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

    Code Info

    Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020

    Distribution

    US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None

    Quantity

    460