Events

Retiro De Equipo (Recall) de Angiotech Pediatric Bone Marrow Needle

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medical Device Technologies, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    54688
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2019-2010
  • Fecha de inicio del evento
    2009-09-01
  • Fecha de publicación del evento
    2010-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92381
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Instrument, biopsy - Product Code KNW
  • Causa
    Medical device technologies doing business as angiotech has conducted a recall on angiotech breast localization needles, soft tissue biopsy needles, vascular access needles, bone biopsy needles, access needles, galactography kit, stabilization needles and needle guides for packaging integrity.
  • Acción
    Angiotech sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated September 1, 2009, to all customers. on September 2, 2009 by UPS 2nd day delivery with an assigned tracking number. The letter described the product, problem and action to be taken by customers. The customers were instructed to please review your current inventory and segregate the affected lot numbers, complete the attached Customer Acknowledgement Form and return via fax to our Quality Assurance department at 1-352-338-0662 or 1-800-333-0440. If you are a distributor of this product, you are responsible for notifying any customer you may have sold the product to. If you have any questions concerning this notification, please contact Shannon Brooks at (352) 338-0440 ext.355 or Katrenia Williams at ext. 353.

Device

Angiotech Pediatric Bone Marrow Needle
  • Modelo / Serial
    90571SUX, 90761T8O, 91131TZQ.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
  • Descripción del producto
    Angiotech Pediatric Bone Marrow Needle. || Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k || K980196. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended Use: Pediatric Bone Marrow Needle
  • Manufacturer
    Medical Device Technologies, Inc.

Manufacturer

Medical Device Technologies, Inc.
  • Dirección del fabricante
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Empresa matriz del fabricante (2017)
    RoundTable Healthcare Partners Lp
  • Source
    USFDA