Events

Rappel de Device Recall ENDOPATH Probe Plus II

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 Ethicon Endo-Surgery 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
    50510
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0663-2009
  • Date de mise en oeuvre de l'événement
    2008-12-09
  • Date de publication de l'événement
    2009-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75727
  • 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
    Electrosurgery Probe - Product Code GCJ
  • Cause
    Nickel exposure: the stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. ethicon endo-surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens.
  • Action
    On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.

Device

Device Recall ENDOPATH Probe Plus II
  • Modèle / numéro de série
    Product code EPS09 - Lot # E4KC2H, Exp. Date 2013-01; Lot # E4KJ1H, Exp. Date 2013-02; Lot # E4KR73, Exp. Date 2013-03; Lot # E4KW8R, Exp. Date 2013-03; Lot # E4L465, Exp. Date 2013-04; Lot # E4LA5T, Exp. Date 2013-05; Lot # E4LD9H, Exp. Date 2013-05; Lot # E4LF6M, Exp. Date 2013-05; Lot # E4LK7U, Exp. Date 2013-06; Lot # E4LU3N, Exp. Date 2013-07; Lot # E4M33D, Exp. Date 2013-08; Lot # E4M69J, Exp. Date 2013-09; and Lot # E4M83N, Exp. Date 2013-09.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.
  • Description du dispositif
    Ethicon Endo-Surgery ENDOPATH¿ Electrosurgery Probe Plus II 29 cm Needle Probe (Product Code EPS09)
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA