Events

Rappel de Device Recall RediGuard IAB

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 Arrow International, Inc., Division of Teleflex Medical Inc..

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
    73266
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1061-2016
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143678
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Cause
    The sheath body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device.
  • Action
    The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. 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 RediGuard IAB
  • Modèle / numéro de série
    Batch:18F14A0041 18F14C0003 18F14C0006 18F14C0021 18F14C0026 18F14C0027 18F14C0028 18F14E0039 18F14E0055 18F14E0058 18F14F0035 18F14F0038 18F14F0054 18F14G0057 18F14G0077 18F14H0011 18F15B0023 18F15C0001 18F15C0008 18F15C0026 18F15D0028 18F15F0027 18F15F0037 18F15G0003 18F15G0011 18F15G0032 18F15H0046 18F15M0009
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
  • Description du dispositif
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
  • Manufacturer
    Arrow International, Inc., Division of Teleflex Medical Inc.

Manufacturer

Arrow International, Inc., Division of Teleflex Medical Inc.
  • Adresse du fabricant
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA