BEUDAMED
    FDA Recall Terminated

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    Recall: Z-2766-2016 · Initiated August 2, 2016

    Recall

    Recall Number
    Z-2766-2016
    Event Number
    74839
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    GDF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 2, 2016
    Posted
    September 8, 2016
    Terminated
    March 30, 2017
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    Reason

    Tip Breakage at the glue joint between the obturator body and tip

    Action

    Hologic sent an Important Product Recall letter to customers in the United States through Certified letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory and cease use of all affected recalled product. Customers were asked to complete the enclosed Recall Response Card indicating whether you have any of the recalled product on hand, as well as the quantity of product that you have in stock.

    Distribution

    US Nationwide Distribution

    Quantity

    535 units