Events

Recall of Device Recall GENERAL PROCEDURE KIT

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

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
    52683
  • Event Risk Class
    Class 2
  • Event Number
    Z-2108-2009
  • Event Initiated Date
    2009-07-13
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83720
  • 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
    Syringe, piston - Product Code CAZ
  • Reason
    Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
  • Action
    Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.

Device

Device Recall GENERAL PROCEDURE KIT
  • Model / Serial
    Lot number W0905021
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
  • Product Description
    Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. || Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
  • Manufacturer
    Integra Life Sciences Corporation

Manufacturer

Integra Life Sciences Corporation