Events

Recall of Device Recall Integra Cranial Access Kit

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

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
    66949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0551-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2013-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124276
  • 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
    Shunt, Central Nervous System And Components - Product Code JXG
  • Reason
    Integra lifesciences is voluntarily recalling any unexpired lots of hithsp10 cranial access kits due to identified labeling discrepancies. kit contains duraprep and monocryl sutures whose labeling does not align with the intended use and labeling of the cranial access kit.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated November 26, 2013, to all affected consignees. The letter identified the product, the problem, the action to be taken by the consignee and included a Recall Acknowledgement and Return form. Consignees were instructed to review their inventory and determine if they have any affected product, stop using the affected product immediately and remove from service. Consignees were instructed to complete the attached form even if they do not have the affected product in their inventory and return by email or fax as indicated on the form. When the form is received Customer Service will send an RMA number and directions to return the product. Customers with questions were instructed to contact Customer Service at 1-855-532-1723 or their Integra sales representative at 909-201-4099. For questions regarding this recall call 609-936-6822.

Device

Device Recall Integra Cranial Access Kit
  • Model / Serial
    Lot No. W1302120 Expires 2/1/2014  Lot No. W1305038 Expires 8/1/2015  Lot No. W1306137 Expires 9/1/2014
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. || Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Manufacturer Address
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Manufacturer Parent Company (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA