Events

Recall of Device Recall Centurion Convenience Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Centurion Medical Products Corporation.

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
    73168
  • Event Risk Class
    Class 2
  • Event Number
    Z-0861-2016
  • Event Initiated Date
    2016-01-19
  • Event Date Posted
    2016-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143304
  • 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
    Convenience kits contain an in-vision-plus needleless iv connector, code rym5001 that is being recalled by the manufacturer, rymed technologies, llc. a component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. other components within these kits are not affected.
  • Action
    The firm, RyMed Technologies, LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/4/2016 to the affected customers via certified mail on 1/19/2016 with instructions for identifying and returning the affected product. The recall letter included a description of the reason for the recall, affected product, actions to be taken, and instructions for responding to the formal recall notification. The customers were instructed to discontinue distribution and/or use and return product to: RyMed Technologies, LLC, 6000 W. William Cannon Drive, Building B, Suite 300, Austin, TX 78749; that user facilities change the IV connector within 24 hours when lipids are being administered; if you further distributed any of the lots, contact your accounts, advise them of recall and return their outstanding stock, complete and return enclosed Acknowledgement and Receipt Form ASAP and no later than 10 business days via E-mail: amccutchen@rymedtech.com, Fax: 512-301-7338 or by mail to address above, Attention Recall Return Notification. Please contact Director of Quality Assurance/Regulatory Affairs at (512) 301-7334 Ext.303 or email: ammccutchen@rymedtech.com should you have questions pertaining to recall notification. Questions pertaining to Returning Product/Replacement Product contact Logistics Specialist at (512) 301-7334 Ext.309 or email svara@rymedtech.com.

Device

Device Recall Centurion Convenience Kits
  • Model / Serial
    ECVC1010  CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017  ECVC1025  16CM CENTRAL LINE BUNDLE  Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017  ECVC1425  20CM CENTRAL LINE BUNDLE  Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017  ECVC1780  TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017  ECVC1785  QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017  ECVC3015  CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017  ECVC3260  CVC INSERT BUNDLE 16CM  Batch Exp. 2015061150 09/2016 2015061550 09/2016  ECVC3540  TRIPLE LUMEN PI CVC BUNDLE  Batch Exp. 2015041350 12/2016  ECVC3575  CVC TRIPLE LUMEN BUNDLE - 20CM  Batch Exp. 2015041550 10/2016 2015061050 01/2017  ECVC3915  VANTEX TLC KIT: CURVED SUTURE NEEDLE  Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017  ECVC3925  9F INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017  ECVC405  CVC MULTI-LUMEN INSERTION BUNDLE  Batch Exp. 2015041750 12/2016 2015061050 01/2017  ECVC4095  AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016  ECVC4110  MULTI-MED TLC KIT: CURVED SUTURE NDL  Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017  ECVC4115  6FR INTRODUCER: CURVED SUTURE NEEDLE  Batch Exp. 2015080550 01/2017  ECVC4170  AVA 3xi CVC BUNDLE  Batch Exp. 2015070250 06/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
  • Product Description
    Convenience Kits from Centurion that contain an In-Vision- || Plus Needleless IV Connector, Model: code RYM5001 || InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
  • Manufacturer
    Centurion Medical Products Corporation

Manufacturer

Centurion Medical Products Corporation
  • Manufacturer Address
    Centurion Medical Products Corporation, 100 Centurion Way, Williamston MI 48895-9086
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA