Events

Recall of Device Recall Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics, 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
    49042
  • Event Risk Class
    Class 2
  • Event Number
    Z-2398-2008
  • Event Initiated Date
    2008-07-07
  • Event Date Posted
    2008-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72579
  • 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
    Implanted Hemodialysis Catheter - Product Code MSD
  • Reason
    The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.
  • Action
    AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to AngioDynamics. 3. Ship the recalled product(s) to AngioDynamics. Consignees will be credited for the returned products. Credits will only be issued for returned product that is within the scope of the recall. Reference Return Authorization Number ___ on the outside of the shipping box and include a copy of the Centros Recall Reply Form with the return shipment. --- The letters also provide actions to be taken for product(s) in use: ANGIODYNAMICS recommends that physicians continue to follow facility protocols for inserting dialysis catheters and monitoring dialysis catheter patients. It is recommended that physicians consider evaluation of patients with an indwelling Centros catheter to assure the catheter is properly secured. As stated in the product's instructions for use, it is recommended that the catheter be secured/sutured for the entire duration of implantation. If the sutures have been cut, consider re-suturing to maintain proper catheter position. Do not rely on ingrowth of the cuff to maintain proper catheter position. This failure does not affect the function or integrity of the catheter itself and there have no reports of patient injury due to this problem. For questions, concerns, or more detailed instructions on how to

Device

Device Recall Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set
  • Model / Serial
    Lots S08B03, S08C03, S08C04, and S08C08
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From Tip), Catalog No./REF 10303103. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY USA 12804.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12801
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA