Events

Rappel de Device Recall Percuvance Johans Grasper Tool Tip

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
    77974
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3221-2017
  • Date de mise en oeuvre de l'événement
    2017-07-19
  • 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=158548
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. for certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated July 19 , 2017, to all affected consignees communicating the following on their recall of Percuvance Percutaneous Surgical System: Consignees were advised to take the following actions. 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 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 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 products 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 allow us to document your receipt of this letter. Customers with any other questions, should contact their local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Percuvance Johans Grasper Tool Tip
  • Modèle / numéro de série
    Lot #'s: 73A1600104, 73B1600339, 73C1600291, 73C1600454, 73D1600586, 73E1600586, 73G1600016, 73G1600558, 73G1600728, 73H1600148, 73H1600507, 73H1600901, 73J1600061, 73J1600601, 73L1600024, 73L1600376, 73L1600559, 73M1500035, and 73M1500300
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
  • Description du dispositif
    Percuvance Johans Grasper Tool Tip || The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville NC 27560-5437
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA