Events

Rappel de Device Recall Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm

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
    68332
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1786-2014
  • Date de mise en oeuvre de l'événement
    2014-05-16
  • Date de publication de l'événement
    2014-06-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127366
  • 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, cholangiography - Product Code GBZ
  • Cause
    Several complaints were received for the metal support tube missing from the cholangiogram catheter.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification dated May 16, 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. Immediately discontinue distribution and quarantine any products with the catalog numbers and lot numbers listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. 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. 5. If you and your customers 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 Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm
  • Modèle / numéro de série
    Product Code 18400, Lot No. 01A1400037
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including the states of AL, AZ, AR, CA, CO, FL, IL, LA, ME, MI, MO, NY, OH, OR, TN, TX, VT and WI., and the country of Belgium.
  • Description du dispositif
    Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm || To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
  • 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