Events

Rappel de Biliary Catheters

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 Applied Medical Resources Corp.

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
    63100
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2447-2012
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • Date de publication de l'événement
    2012-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112547
  • 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, biliary, diagnostic - Product Code FGE
  • Cause
    Applied medical is recalling specific lot numbers of its vascular catheters because they may have a potential for packaging particulate matter to reside on the product.
  • Action
    Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to recall60476587@appliedmedical.com or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.

Device

Biliary Catheters
  • Modèle / numéro de série
    Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
  • Description du dispositif
    Biliary Catheters (Models A47XX and CB0XXXXX): || Model Numbers & Description: || A4752, SYNTEL BILIARY 5F-23CM CATHETER; || A4754, SYNTEL BILIARY 5F-40CM CATHETER; || A4762, SYNTEL BILIARY 6F-23CM CATHETER; || CB052308, SYNTEL BILIARY 5F-23CM CATH; || CB054008, SYNTEL BILIARY 5F-40CM CATH; || CB062313, SYNTEL BILIARY 6F-23CM CATH. || Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Adresse du fabricant
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Société-mère du fabricant (2017)
    Applied Medical Corporation
  • Source
    USFDA