Events

Recall of Device Recall CUSA NXT Ultra Surgical Aspirator System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    56463
  • Event Risk Class
    Class 2
  • Event Number
    Z-2638-2010
  • Event Initiated Date
    2010-07-29
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93734
  • 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
    A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the cusa nxt service module to run at maximum speed, and continue to run until the entire system is turned off. this may result in excess aspiration that requires medical intervention.
  • Action
    Integra issued Urgent: Product Recall Notification letters dated July 29, 2010 to all customers on July 29, 2010 identifying the affected products, issue prompting the recall, and actions to be taken by the customer. Letters were also forwarded to all Integra Account Reps. Customers were advised to discontinue use of and quarantine the affected service modules. The Surgical Aspirator may be operated without the Service Module, utilizing the hospitals wall aspiration. Company representatives will contact customers to arrange product return and repair of the affected service modules. Customers are to complete and return an enclosed Recall Acknowledgement and Return Form. The firm can be contacted at 609 936-2485.

Device

Device Recall CUSA NXT Ultra Surgical Aspirator System
  • Model / Serial
    Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.
  • Product Description
    Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT2: Latex Free, Rx only. || Integra LifeSciences (Ireland) Limited || County Offaly, Ireland || Distributed by Integra Lifesciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.