Events

Rappel de Device Recall Auto Endo5 Hemolok Automatic Clip Applier

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
    73181
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0886-2016
  • Date de mise en oeuvre de l'événement
    2016-02-02
  • Date de publication de l'événement
    2016-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143353
  • 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
    Clip, implantable - Product Code FZP
  • Cause
    The clip in the applier may be missing a boss. a boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated February 2, 2016 to customers. The letter identified the affected product, problem and actions to be taken. A separate letter was sent to distributors advising them to conduct a sub-recall. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the letter. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1- 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.This will 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 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will document receipt of the letter. For questions contact your local sales representative or Customer Service at 1-866-246-6990

Device

Device Recall Auto Endo5 Hemolok Automatic Clip Applier
  • Modèle / numéro de série
    73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium
  • Description du dispositif
    Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 || Product Usage: || The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA