Events

Rappel de Device Recall The Rush Endobronchial Tube set

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teleflex Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67630
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1231-2014
  • Date de mise en oeuvre de l'événement
    2014-02-28
  • Date de publication de l'événement
    2014-03-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125870
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Tube, bronchial (w/wo connector) - Product Code BTS
  • Cause
    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.

Device

Device Recall The Rush Endobronchial Tube set
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA