BEUDAMED
    FDA Enforcement Class II Terminated

    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

    Recall: Z-2498-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2498-2020
    Event ID
    85787
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 3, 2020
    Classification Date
    July 4, 2020
    Termination Date
    May 11, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350, United States

    Description

    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176

    Reason

    Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator

    Code Info

    Lot 284288 - Expiration date: 02/24/2023

    Distribution

    Nationwide

    Quantity

    2,250 units (45 boxes of 50)