Retiro De Equipo (Recall) de Device Recall TLok Bone Marrow Tray

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Single use instrument tray kit - Product Code OJV
  • Causa
    Medical device technologies, inc. dba angiotech, is recalling hsg procedure trays and bone biopsy trays distributed between december 2007 and december 14, 2010 for package integrity.
  • Acción
    The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.


  • Modelo / Serial
    Catalog # BMT1104BTL Lot Number(s): 90901TID; 91061TUR; 91311UAN; 91541URR; 91541URS; 91611UYC; 91611UYD; 91701V4P; 91821V65; 92191W5U; 92241W8L; 92381WGP; 92661WYK; 92681X1T; 92681X1U; 92721X4H; 92851XBC; 93201XVY; 93211XYD; 93291Y3S; 00131YKH; 00461ZER; 00461ZFF; 00611ZPO; 00671ZRJ; 00751ZYG; 0077200G; 0078200O; 011820P6; 013020WD; 0138212B; 0139213P; 016821KT; 017621P9; 017621PA; 0208227F; 022822I3; 024622UC; 02602315; 0264232Z; 028023D4; 030923WL; 03222469.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • Descripción del producto
    Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 2 - 4mL Specimen Tube w/EDTA; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap; ***Catalog Number: BMT1104BTL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466,, || Intended for the purpose of harvesting bone and/or bone marrow specimens.
  • Manufacturer


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