Events

Recall of Device Recall Henora

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

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
    68552
  • Event Risk Class
    Class 2
  • Event Number
    Z-1996-2014
  • Event Initiated Date
    2014-03-28
  • Event Date Posted
    2014-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128179
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
  • Action
    RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI

Device

Device Recall Henora
  • Model / Serial
    Lot numbers 102131 and 110531.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
  • Product Description
    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set || Product Usage: || Catheter extension set for high pressure procedures.
  • Manufacturer
    RGI Medical Manufacturing, Inc.

Manufacturer

RGI Medical Manufacturing, Inc.
  • Manufacturer Address
    RGI Medical Manufacturing, Inc., 4637 NW 6th St, Gainesville FL 32609-0701
  • Manufacturer Parent Company (2017)
    Rgi Medical Manufacturing Inc.
  • Source
    USFDA