Events

Recall of Safe Sheath ULTRALITE 8F Safe Sheath Introducer.

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
    59526
  • Event Risk Class
    Class 2
  • Event Number
    Z-0055-2012
  • Event Initiated Date
    2011-08-01
  • Event Date Posted
    2011-10-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103021
  • 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
    The product may contain an incorrect size catheter and introducer.
  • Action
    AngioDynamics, Inc contacted affected customers initially via telephone and a follow up "Notification of Medical Device Correction" letter was sent dated August 1, 2011. The letter informed them of the problem and provided instructions. Customers were instructed to utilize the 8F Introducer Sheath provided within the 8F Smart Port CT Implantable Port during port implantation. The 8F Valved Sheath (V18) may continue to be utilized during the placement of the 7.5F Smart Port Implantable Port (for example: CT75STSD; CT75STSD-NF). For question on this recall contact AngioDynamics, Inc at (800) 772-6446.

Device

Safe Sheath ULTRALITE 8F Safe Sheath Introducer.
  • Model / Serial
    Catalog number: V18, Lot numbers D1-01664 and D101799
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide distribution including the states of CA, FL, GA, IA, IL, IN, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, TN, UT, WA and WI.
  • Product Description
    8F Safe Sheath Introducer, Catalog number: V18; || AngioDynamics, INC. || The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
  • Manufacturer
    Angiodynamics, INC

Manufacturer

Angiodynamics, INC
  • Manufacturer Address
    Angiodynamics, INC, 1 Horizon Way, Manchester GA 31816-1749
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA