BEUDAMED
    FDA Recall 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 · Initiated October 27, 2014

    Recall

    Recall Number
    Z-0488-2015
    Event Number
    69642
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HHK
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 27, 2014
    Posted
    December 1, 2014
    Terminated
    May 28, 2015
    Address
    75 Vista Pl, Trumbull, CT, 06611-3934

    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.

    Action

    CooperSurgical sent an Recall letter dated October 27, 2014, via UPS to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The subject device does not meet the required release specification as it contains an incorrect curette type. No adverse events or injuries have been reported to date in connection with the use of the CANNULA CURETTE. The event was discovered during internal investigation. Products that do not meet the above criteria are safe to use alongside the DFU guideline.The letter requests that customers return the recalled product for a full refund or exchange. If you have any further questions please feel free to call (203) 601.5200.

    Distribution

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

    Quantity

    30