BEUDAMED
    FDA Recall 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 · Initiated June 3, 2020

    Recall

    Recall Number
    Z-2498-2020
    Event Number
    85787
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    LOB
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 3, 2020
    Terminated
    May 11, 2021
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    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

    Action

    Cooper Surgical issued letter dated 6/3/20/20 via Certified Mail stating reason for recall, health risk and action to take: Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice. CooperSurgical contact:: 203-601-5200 ext. 3300.

    Distribution

    Nationwide

    Quantity

    2,250 units (45 boxes of 50)