Events

Recall of Device Recall RYM5000 InVisionPlus Neutral Displacement I.V. Connector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rymed Technologies, 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
    36854
  • Event Risk Class
    Class 2
  • Event Number
    Z-0319-2007
  • Event Initiated Date
    2006-05-25
  • Event Date Posted
    2006-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49457
  • 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
    I.V. Connectors - Product Code FPA
  • Reason
    Weld failures on iv connector (area of female luer and spike body).
  • Action
    Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.

Device

Device Recall RYM5000 InVisionPlus Neutral Displacement I.V. Connector
  • Model / Serial
    Lots #400, 401, and 402.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Recall
  • Product Description
    RYM-5000 InVision-Plus¿ Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.
  • Manufacturer
    Rymed Technologies, Inc.

Manufacturer

Rymed Technologies, Inc.
  • Manufacturer Address
    Rymed Technologies, Inc., 6000 W. William Cannon Drive, Bldg. B, Suite 300, Austin TX 78749
  • Source
    USFDA