Events

Recall of Device Recall Nipro Safetouch, Baxter Safety AV, EXEL Secure Touch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nipro 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
    25052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0408-03
  • Event Initiated Date
    2002-11-08
  • Event Date Posted
    2003-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25078
  • 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
    Needle, Fistula - Product Code FIE
  • Reason
    Air or fluid leakage at the hub/needle junction.
  • Action
    The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.

Device

Device Recall Nipro Safetouch, Baxter Safety AV, EXEL Secure Touch
  • Model / Serial
    All lot numbers in current distribution are under recall.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    The following brand name labeled products are under recall (all || catalog numbers and all lot numbers under recall): || NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula || Set and EXEL Secure Touch Safety AV Fistula Needle Set.
  • Manufacturer
    Nipro Corp

Manufacturer

Nipro Corp
  • Manufacturer Address
    Nipro Corp, 3150 NW 107th Avenue, Brokers Box 97, Miami FL 33172
  • Source
    USFDA