Events

Recall of NAMIC Custom Angiographic Kit

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

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
    49571
  • Event Risk Class
    Class 2
  • Event Number
    Z-0287-2009
  • Event Initiated Date
    2008-08-06
  • Event Date Posted
    2008-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73828
  • 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
    Cardiopulmonary Bypass Oxygenator - Product Code DTZ
  • Reason
    Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
  • Action
    On 8/12/08, Navilyst Medical sent a fax and phoned the sole domestic hospital account that had received the affected units. Navilyst Medical instructed the consignee to immediately locate, segregate, and quarantine the units. The hospital consignee confirmed that all units were still in their control and that they will maintain them in quarantine awaiting return to Navilyst Medical. The sole international account, Boston Scientific in Ireland was notified of the problem on 8/06/08. This was followed up with an Urgent Medical Device Recall Letter and Verification Form sent via FedEx on 8/20/08.

Device

NAMIC Custom Angiographic Kit
  • Model / Serial
    UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of MO and country of Ireland.
  • Product Description
    NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. || Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
  • Manufacturer
    Navilyst Medical

Manufacturer

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