Events

Rappel de Applied Medical's LAP CHOLE KIT 1A; Model Number: K0522

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
    57702
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1509-2011
  • Date de mise en oeuvre de l'événement
    2010-09-10
  • Date de publication de l'événement
    2011-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97040
  • 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
    Laparoscope, general &: plastic surgery - Product Code GCJ
  • Cause
    Applied medical is conducting a voluntary recall of specific lot numbers of the direct drive laparoscopic clip applier, model number ca090, due to a potential defect in the jaws, possibly resulting in jaw breakage.
  • Action
    Applied Medical sent an URGENT: MEDICAL DEVICE RECALL letter dated September 10, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and complete the attached Voluntary Recall Notification Confirmation Form and fax it to 949-713-8832. Customers were asked to return all affected product. Secondary consignees were notified by Applied Medical on September 16, 2010. For any questions regarding this recall call 949-713-8041.

Device

Applied Medical's LAP CHOLE KIT 1A; Model Number: K0522
  • Modèle / numéro de série
    LOT NUMBER(S): 1121811
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.
  • Description du dispositif
    Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.
  • 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