BEUDAMED
    FDA Enforcement Class II Terminated

    Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.

    Recall: Z-0147-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0147-2015
    Event ID
    69446
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc. D.B.A. Lone Star Medical Products
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    September 13, 2013
    Classification Date
    October 29, 2014
    Termination Date
    September 23, 2015
    Address
    11211 Cash Rd, N/A, Stafford, TX, 77477-4310, United States

    Description

    Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.

    Reason

    CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.

    Code Info

    Lots 149460 and 149911

    Distribution

    Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.

    Quantity

    90 units