Events

Rappel de Device Recall Endobronchial Tubes

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
    52823
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1940-2009
  • Date de mise en oeuvre de l'événement
    2009-07-31
  • Date de publication de l'événement
    2009-09-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84075
  • 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
    Connector, airway (extension) - Product Code BZA
  • Cause
    The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
  • Action
    Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.

Device

Device Recall Endobronchial Tubes
  • Modèle / numéro de série
    Catalog Number: 5-15301, Lot Numbers: 1132962, 1135424, 1136773, 1169645, 1173522, 1178399, 1188200, 1186993, 1194489,1201020, 1212344, 1258338, 1269036, 01L0700243, 01A0800245, 01C0800104, 01E0800341, 01F0800283, 01F0800354, 01L0800005, 01M0800250 and 01A0900036; and   Catalog Number: 5-15401, Lot Numbers: 1152620, 1153518, 1153626, 1155031, 1156400, 1156986, 1157666, 1160298, 1164076, 1169644, 1168080, 1172007, 1173521, 1182297, 1186762, 1193750, 1195118, 1276554, X1198365, X1198635, 01B0800103, 01F0800284, 01G0800362, 01H0800175, 01J0800015, 01A0900367 and 01D0900087.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
  • Description du dispositif
    Hudson RICA¿ Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. || Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
  • 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