Events

Recall of Device Recall Hemodialysis System and Accessories

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medisystems 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
    61184
  • Event Risk Class
    Class 2
  • Event Number
    Z-1126-2012
  • Event Initiated Date
    2012-01-31
  • Event Date Posted
    2012-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107478
  • 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
    Mislabeled outer carton: outside shipping cartons is stamped 15ga x 1", product contained within properly labeled as 17ga x 1" needle.
  • Action
    Medisystems Corporation issued notice of recall to distributors on January 31, 2012. Distributors to notify affected end users by letter. Each letter was accompanied by a response form and instructions on how to return the response form. End users were given the option of returning involved product for credit or replacement. Contact Medisystems Quality Assurance Manager at (978) 332-5973 for information.

Device

Device Recall Hemodialysis System and Accessories
  • Model / Serial
    Lot Numbers: 110914F7, 110920F2
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AZ, CA, CO, OR, NV, NY, TN, and WA.
  • Product Description
    Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" || Ref. Number: D9-2007MG. || Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector.
  • Manufacturer
    Medisystems Corp

Manufacturer

Medisystems Corp
  • Manufacturer Address
    Medisystems Corp, 439 S Union St Fl 5th, Lawrence MA 01843-2837
  • Manufacturer Parent Company (2017)
    Nxstage Medical Inc
  • Source
    USFDA