Events

Recall of External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.

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

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
    25255
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-03
  • Event Initiated Date
    2002-12-16
  • Event Date Posted
    2003-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25470
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code LID
  • Reason
    The check valve in the patient line may stick in the closed position.
  • Action
    Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.

Device

External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
  • Model / Serial
    The External Drainage Sets lot numbers: 60300370, 60306608, 60306609, 60321387, 60300373, and 60376191. These lots of EDS may be included in the following set configurations:  Catalog #: 910-109 Lot#: 0118080; 0118369; 0118572; 0118981; 0119845; 0117525.  Catalog# 910-110A Lot #: 60300370; 60300373; 60306608; 60300370-1; 60321387; 60306608-1; 60306609; 60321387-1; 60306609-1; 60321387-2; 60376191; 60321387-3.  Catalog# 910-112A Lot #: 0117569; 0117609; 0117834; 0117478; 0117833; 0117957; 0118062; 0118175; 0118420; 0118421; 0118573; 0118693.  Catalog #910-118A Lot#: 0117570; 0117479; 0118023; 0118489; 0119150; 0119505.  Catalog #910-120A Lot #: 0117536; 0117371; 0117453; 0117537; 0117902; 0117948; 0118047; 0118161; 0118422; 0118543; 0118616; 0118744; 0118808; 0118912; 0118955; 0119020; 0119081; 0119348; 0119500; 0119582.  Catalog #910-123A Lot #: 0117805; 0118576; 0118845; 0118957.
  • Product Classification
    Neurological Devices
  • Distribution
    The affected products have been distributed to hospitals, distributors, and Integra Sales Representatives. There are 202 direct hospital customers, 5 foreign distributors, and 1 wholesaler. Government distribution include the National Institute of Health in Bethesda, MD and 9 Veterans Administration Hospitals. International distributions to the following countries: United Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, Gabron, United Kingdom, Greece, Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Sweden, Turkey, South Africa, and Mexico.
  • Product Description
    External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp
  • Manufacturer Address
    Integra LifeSciences Corp, 105 Morgan Lane, Plainsboro NJ 08536
  • Source
    USFDA