Events

Rappel de LeMaitre

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 LeMaitre Vascular, 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
    72534
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0385-2016
  • Date de mise en oeuvre de l'événement
    2015-10-21
  • Date de publication de l'événement
    2015-12-04
  • 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=141783
  • 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, embolectomy - Product Code DXE
  • Cause
    Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
  • Action
    Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.

Device

LeMaitre
  • Modèle / numéro de série
    Lot Number: OTW3099¿
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
  • Description du dispositif
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. || Indicated for the removal of arterial emboli and thrombi.
  • Manufacturer
    LeMaitre Vascular, Inc.

Manufacturer

LeMaitre Vascular, Inc.
  • Adresse du fabricant
    LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Société-mère du fabricant (2017)
    LeMaitre Vascular, Inc.
  • Source
    USFDA