BEUDAMED
    FDA Enforcement Class II Terminated

    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

    Recall: Z-0534-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0534-2013
    Event ID
    63808
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arobella Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    November 5, 2012
    Classification Date
    December 17, 2012
    Termination Date
    March 4, 2015
    Address
    5929 Baker Rd Ste 470, Minnetonka, MN, 55345-4770, United States

    Description

    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

    Reason

    This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

    Code Info

    0001 and 0002

    Distribution

    Worldwide distribution - US (nationwide) and the states of AL, CA, ID, IN, IA, MI, MN, MS, NJ, NM, OH, PA. SC, TX, UT, VA, WI. including the country of SAUDI ARABIA.

    Quantity

    99