BEUDAMED
    FDA Enforcement Class II Terminated

    Pereyra Ligature Carrier 75

    Recall: Z-2535-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2535-2017
    Event ID
    77217
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    April 25, 2017
    Classification Date
    June 14, 2017
    Termination Date
    March 26, 2019
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Pereyra Ligature Carrier 75

    Reason

    reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

    Code Info

    All lots Catalog numbers J-PLC-751810 and 090100

    Distribution

    The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

    Quantity

    29