BEUDAMED
    FDA Recall Terminated

    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.

    Recall: Z-2201-2012 · Initiated July 17, 2012

    Recall

    Recall Number
    Z-2201-2012
    Event Number
    62588
    Firm
    Nico Corp.
    FEI Number
    3007456622
    Product Code
    GZT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 17, 2012
    Posted
    August 13, 2012
    Terminated
    November 7, 2012
    Address
    12263 Bridgewater Rd, Indianapolis, IN, 46256-9428

    Description

    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.

    Reason

    BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.

    Action

    NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form. Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical. For questions customers should call 888-632-7071.

    Distribution

    Worldwide Distribution - USA including MI and Canada

    Quantity

    15 devices (3 boxes, 5 devices per box)