Events

Recall of Device Recall InVisionPlus CS Needleless IV Connector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rymed Technologies, LLC.

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
    72997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0676-2016
  • Event Initiated Date
    2016-01-05
  • Event Date Posted
    2016-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142693
  • 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
    Potential for the female luer component of the invision-plus iv connector to crack during use.
  • Action
    The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: amccutchen@rymedtech.com, fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: amccutchen@rymedtech.com or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: svara@rymedtech.com or call 512-301-7338x309.

Device

Device Recall InVisionPlus CS Needleless IV Connector
  • Model / Serial
    Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. || Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
  • Manufacturer
    Rymed Technologies, LLC

Manufacturer

Rymed Technologies, LLC
  • Manufacturer Address
    Rymed Technologies, LLC, 6000 W William Cannon Dr Ste B300, Austin TX 78749-1991
  • Source
    USFDA