BEUDAMED
    FDA Recall Terminated

    CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

    Recall: Z-2112-2020 · Initiated April 9, 2020

    Recall

    Recall Number
    Z-2112-2020
    Event Number
    85544
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HIH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 9, 2020
    Terminated
    May 11, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

    Reason

    The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

    Action

    CooperSurgical sent an Urgent Medical Device Recall letter dated April 9, 2020 to all customers that received lot number 257589 of the Milex Cervical Dilator P/N MX21 which could have a compromised finished seal (opposite the chevron seal) of the sterile pouch. Customers were instructed to inspect each package for damage, including the seal area, prior to use (product is acceptable for use if it is visually confirmed that the pouchs seal is intact). Customers should discontinue use of and quarantine products with any packaging irregularities. The firm requested that the customers complete and return the attached Acknowledgement and Receipt Form, whether or not they had any of the affected product on hand. CooperSurgical stated that they will arrange for product returns and replacement.

    Distribution

    Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI

    Quantity

    1740 units/174 boxes