BEUDAMED
    FDA Recall Terminated

    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.

    Recall: Z-1231-2014 · Initiated February 28, 2014

    Recall

    Recall Number
    Z-1231-2014
    Event Number
    67630
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BTS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 28, 2014
    Posted
    March 19, 2014
    Terminated
    September 28, 2016
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.

    Reason

    The product may fail to achieve seal of right lung due to the cuff inflating to one side

    Action

    Teleflex sent a Urgent Medical Device Recall Notification dated February 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV and WI,and the countries of United Arab Emirates, Austria, Australia, Azerbaijan, Belgium, Belgrade, Bahrain, Canada, Switzerland, Cameroon, China, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guyana, Croatia, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Serbia, Malaysia, Martinique, Nigeria, Netherlands, Norway, Oman, Panama, French Polynesia, Philippines, Poland, Portugal, Qatar, Reunion, Russia, San Salvador, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, San Marino, Thailand, Trinidad, Tunisia, Turkey, Venezuela, Yemen and Zambia

    Quantity

    63,568 ea.