Events

Recall of Device Recall Integra Suction Reservoir with AntiReflux Valve

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
    55708
  • Event Risk Class
    Class 2
  • Event Number
    Z-2588-2010
  • Event Initiated Date
    2010-05-07
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91622
  • 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
    Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
  • Reason
    The sterility of the product may be compromised. integra lifesciences corp. received a recall notification from saint-gobain performance plastics, france, contract manufacturer of the integra suction reservoir with anti-reflux valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier.
  • Action
    Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form" Integra LIfeSciences can be contacted at 609-936-2495.

Device

Device Recall Integra Suction Reservoir with AntiReflux Valve
  • Model / Serial
    Catalog number: 910-500: lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155. Catalog number: 31223; lot numbers 158817, 156484. 157140, 157345, 156618; Catalog number: 31253: lot numbers: 158817, 156484, 157345, 158690, 156618.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka.
  • Product Description
    Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; || Sterile, Rx only. || Manufactured by Integra NeuroSciences Implants S.A., || Sophia Antipolis Cedex, France; || distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; || This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits under catalog number 31223 and 31253.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.