Events

Recall of Stiffened Micro Introducer KIts

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
    75420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0777-2017
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150295
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Greatbatch medical the manufacturer of the 4f and 5f sheath/dilator components has determined that the products listed in their september 7, 2016 recall notification have the potential for the rotating luer to detach from the dilator hub during use. angiodynamics has confirmed that affected sheath/dilators (greatbatch model numbers 10904-001 and 10904-002) have been included in packaged angiodynamics stiffened micro-introducer kits.
  • Action
    Angiiodynamics sent an Urgent Voluntary Medical Device Recall letter dated September 28, 2016, to all affected customers. Recall notifications were delivered by Federal Express. Customers were instructed to segregate and return all affected devices to AngioDynamics and to complete and return the Reply Verification Tracking Form, provided in the recall notification by fax to 1-800-782-1357. Customers were encouraged to forward a copy of the recall notification to all sites to which have distributed affected product. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) 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); following the directions on this page and the Reply Verification Tracking Form via to recall@angiodynamics.com. Customers with questions should contact customer service at 1-800-772-6446.

Device

Stiffened Micro Introducer KIts
  • Model / Serial
    Batch/Lot: 1) 5034280, 5067423, 2) 5061461, 5070972
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
  • Product Description
    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070 || Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA