BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0147-2015 · Initiated September 13, 2013

    Recall

    Recall Number
    Z-0147-2015
    Event Number
    69446
    Firm
    CooperSurgical, Inc. D.B.A. Lone Star Medical Products
    FEI Number
    1627186
    Product Code
    DRC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 13, 2013
    Posted
    October 29, 2014
    Terminated
    September 23, 2015
    Address
    11211 Cash Rd, Stafford, TX, 77477-4310

    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.

    Action

    CooperSurgical sent an Urgent Field Safety Notice ( Correction ) dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm provided correct package inserts (IFU) to affected consignees. The recalling firm intends to conduct effectiveness checks by reviewing return receipts from the initial recall communication. We apologize for any inconvenience this communication may cause. If you have any questions or concerns, please contact CooperSurgical at (203) 601-9818.

    Distribution

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

    Quantity

    90 units