BEUDAMED
    FDA Recall Terminated

    External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.

    Recall: Z-0606-03 · Initiated December 16, 2002

    Recall

    Recall Number
    Z-0606-03
    Event Number
    25255
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    LID
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2002
    Posted
    March 5, 2003
    Terminated
    October 31, 2003
    Address
    105 Morgan Lane, Plainsboro, NJ, 08536

    Description

    External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.

    Reason

    The check valve in the patient line may stick in the closed position.

    Action

    Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.

    Distribution

    The affected products have been distributed to hospitals, distributors, and Integra Sales Representatives. There are 202 direct hospital customers, 5 foreign distributors, and 1 wholesaler. Government distribution include the National Institute of Health in Bethesda, MD and 9 Veterans Administration Hospitals. International distributions to the following countries: United Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, Gabron, United Kingdom, Greece, Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Sweden, Turkey, South Africa, and Mexico.

    Quantity

    8952