Events

Rappel de Device Recall RUSCH

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
    59356
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2935-2011
  • Date de mise en oeuvre de l'événement
    2011-06-30
  • Date de publication de l'événement
    2011-08-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102356
  • 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
    Catheter, urological - Product Code KOD
  • Cause
    Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
  • Action
    Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990

Device

Device Recall RUSCH
  • Modèle / numéro de série
    Product number: 238300140, Lot numbers: 12011, 102728, 105236, 105237, 106237, 106300, 111799, 116422, 117536, 117537, 118157, 118757, 118758, 119911, 121011, 122270, 122279, 122279-1, 134622, 135867, 138384, 140684, 142580, 142581, 142689, 145829, 242221, 310437, 318009, 322171, 325864, 335519, 338391, 340217, 342051, 342052, 350060, 350061, 350062, 351724, 355195, 358832, 359276, 359277, 359992, 378594, 378595, 378596, 379601, 380257, 380258, 380259, 380290, 381735, 384505 and 405525.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and (USA) Nationwide Distribution.
  • Description du dispositif
    RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
  • 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