BEUDAMED
    FDA Enforcement Class III Terminated

    Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.

    Recall: Z-0488-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0488-2015
    Event ID
    69642
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    October 27, 2014
    Classification Date
    December 1, 2014
    Termination Date
    May 28, 2015
    Address
    75 Vista Pl, N/A, Trumbull, CT, 06611-3934, United States

    Description

    Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.

    Reason

    The product has been identified to contain an incorrect curette type.

    Code Info

    Lot Code: 147234

    Distribution

    US Distribution including the states of NY, MO and NV.

    Quantity

    30