Device Recall The Rush Endobronchial Tube set

  • Model / Serial
    Product Code - 116200260, Batch 09LE51, 10GE31, 11LE42, 12DE17, 12IE37, 13CT26, 13DT32; Product Code - 116200280 - Batch 09HE34, 09JE41, 10BE07, 11HE33, 11JE41, 13ET12; Product Code - 116200350 - Batch 0918M, 0915M, 09JE43, 09JE42, 0917M, 11AE03, 11DE15, 11GE27, 09HE34, 11JE43, 11JE42, 12AE02, 12BE07, 12DE17, 12EE19, 12GE27, 12HE33, 13AE01, 13CT26, 13DT33, 13ET12; Product Code 116200370 - Batch 0915M, 0917M, 0914M, 09JE41, 09JE43, 11DE15, 11EE20, 11GE27, 11JE42, 11HE32, 11JE43, 11IE39, 12AE01, 12AE03, 12GE31, 12BE06, 12DE18, 12IE39, 12JE44, 13AT44, 13BT44, 13AE01, 12LE49, 13DT33; Product Code 116200390 - Batch 0914M, 0922M, 0917M, 09JE44, 09FE23, 09HE35, 09JE42, 10GE29, 10AE02, 09JE43, 09KE46, 09LE51, 10AE01, 10CE11, 10DE18, 10EE19, 10JE41, 10EE20, 11DE15, 11KE42, 11GE30, 11HH33, 11IE37, 11IE38, 11IE39, 13AT36, 13BT25, 13BT29; Product Code 116200410 - Batch 0922M, 0915M, 0918M, 09IE36, 09JE43, 10AE05, 10BE06, 10DE16, 10GE28, 10JE41, 11DE15, 11GE27, 11HE34, 11JE43, 13BT44, 13DT32; Product Code 116201350 - Batch 0921M, 09JE40, 09FE23, 13GT05; Product Code 116201370 - Batch 0922M, 0915M, 13AE01, 13ET18, 13HT12, 09FE24; Product Code 116201390 - Batch 09JE44, 10CE10; Product Code 116201410 - Batch 10KE47
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
  • Source
    USFDA