BEUDAMED
    FDA Recall Terminated

    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.

    Recall: Z-2194-2011 · Initiated February 22, 2011

    Recall

    Recall Number
    Z-2194-2011
    Event Number
    58490
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HBG
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 22, 2011
    Posted
    May 13, 2011
    Terminated
    May 13, 2011
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.

    Reason

    Outer packaging of Combo Kit was mislabeled with an incorrect lot number.

    Action

    Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.

    Distribution

    Nationwide Distribution -- including the state of New York.

    Quantity

    7 Kits