BEUDAMED
    FDA Recall Terminated

    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

    Recall: Z-3278-2018 · Initiated September 4, 2018

    Recall

    Recall Number
    Z-3278-2018
    Event Number
    81037
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 4, 2018
    Terminated
    April 15, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

    Reason

    There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

    Action

    Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers to do the following: Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you have no affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.

    Distribution

    Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, Russian Federation, Saudi Arabia, Singapore, Spain, Switzerland, Turkey, and the United Kingdom.

    Quantity

    18,000 units