BEUDAMED
    FDA Enforcement Class II Terminated

    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

    Recall: Z-0533-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0533-2015
    Event ID
    69471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    September 8, 2014
    Classification Date
    December 8, 2014
    Termination Date
    November 29, 2017
    Address
    626 Cooper Ct, N/A, Schaumburg, IL, 60173-4537, United States

    Description

    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

    Reason

    The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

    Code Info

    1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9"; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.

    Distribution

    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

    Quantity

    26 endometrial suction curettes