Events

Recall of Device Recall AR1000 Qoustic Qurette"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arobella Medical, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63808
  • Event Risk Class
    Class 2
  • Event Number
    Z-0534-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2012-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114801
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, ultrasonic surgical - Product Code LFL
  • 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.
  • Action
    Arobella Medical sent an " Urgent: Medical Device Recall" letter dated November 2, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine and return any product subject to the recall. If the affected product have been further distributed, customers were advised to notify their customers of the product recall. For questions call 952-288-2810.

Device

Device Recall AR1000 Qoustic Qurette"
  • Model / Serial
    0001 and 0002
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Arobella Medical, LLC

Manufacturer

Arobella Medical, LLC
  • Manufacturer Address
    Arobella Medical, LLC, 5929 Baker Rd Ste 470, Minnetonka MN 55345-4770
  • Manufacturer Parent Company (2017)
    Arobella Medical Llc
  • Source
    USFDA