Events

Recall of Device Recall NAMIC Convenience Kit

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
    72957
  • Event Risk Class
    Class 2
  • Event Number
    Z-1344-2016
  • Event Initiated Date
    2015-11-03
  • Event Date Posted
    2016-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142588
  • 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
    Cardiovascular procedure kit - Product Code OEZ
  • Reason
    Procedure products initiated the recall due to the inner lumen of the needles not meeting the intended specification. specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. in some cases the inner lumen was found to be 0.036".
  • Action
    On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday EST) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to rdenino@angiodynamics.com or sbaxter@angiodynamics.com.

Device

Device Recall NAMIC Convenience Kit
  • Model / Serial
    Batch/Lot No. 4925152, 4930012; Use By 2018-08
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of CA, IL, MA, SC, TX
  • Product Description
    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 || Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
  • Manufacturer
    AngioDynamics Inc.

Manufacturer

AngioDynamics Inc.
  • Manufacturer Address
    AngioDynamics Inc., 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA