BEUDAMED
    FDA Enforcement Class II Terminated

    Colpo-Pneumo Occluder, Part CPO-6

    Recall: Z-0098-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0098-2019
    Event ID
    80993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2018
    Initiation Date
    September 4, 2018
    Classification Date
    October 11, 2018
    Termination Date
    May 27, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    Colpo-Pneumo Occluder, Part CPO-6

    Reason

    The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

    Code Info

    Lots 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 24 7609, 247610, & 248112

    Distribution

    The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.

    Quantity

    32538