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 York PA, Inc.

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
    68954
  • Event Risk Class
    Class 2
  • Event Number
    Z-2624-2014
  • Event Initiated Date
    2014-07-30
  • Event Date Posted
    2014-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129100
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Reason
    Integra lifesciences has identified through an internal investigation that some colored lids for integra container systems were not yet cleared by the fda for sale and were inadvertently distributed.
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated July 30, 2014, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instricted if they have distributed the affected product, they should identify those customers adn forward a copy of the Integra Medical Device Recall Notice to them. The customer was also instructed to complete the attached form and return by email FCA@integralife.come or FAX to 1-609-275-9445. For questions the customer was asked to contact Customer Service at 1-855-532-1723. For questions regarding this recall call 717-840-9335.

Device

Device Recall Integra
  • Model / Serial
    Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Blue; Container Lid, ¿ Size, Red; Container Lid, ¿ Size, Gold; Container Lid, ¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746
  • Product Description
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, || Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red || Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 || The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
  • Manufacturer
    Integra York PA, Inc

Manufacturer

Integra York PA, Inc