Events

Recall of Device Recall Integra

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
    60798
  • Event Risk Class
    Class 2
  • Event Number
    Z-0748-2012
  • Event Initiated Date
    2011-12-21
  • Event Date Posted
    2012-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106490
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HBG
  • Reason
    Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of xylocaine.
  • Action
    Integra sent an Urgent: Medical Device Correction Notice letter dated December 21, 2011 to all affected customers. The letter identified the product, problem and actions to be taken. Integra is requesting that customers further distribute the communications along with the package insert to all appropriate health care practitioners at their facility. The letter instructs customers to complete and return the attached acknowledgement form by fax to 609-750-7999. For questions or concerns call 609-750-2814.

Device

Device Recall Integra
  • Model / Serial
    167433, 168615, 172611, 174183, 175177, 176045, 178014, 178899, 179758, 180956, 183071, 184686.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution
  • Product Description
    1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contains Sterile and Non-Sterile Product. Integra Life Sciences 3498 West 2400 South, West Valley City, Utah 84119. || Product Usage: The Xylocaine component of the kit is used as an injectable local anesthetic during cranial access operations.
  • 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