Events

Retiro De Equipo (Recall) de Device Recall TLok Ecomony 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
    Recall
  • ID del evento
    57585
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0218-2012
  • Fecha de inicio del evento
    2010-12-22
  • Fecha de publicación del evento
    2011-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96721
  • 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.

Device

Device Recall TLok Ecomony Bone Marrow Tray
  • Modelo / Serial
    Catalog # BMET1104TL Lot Number(s): 81371NG7; 81701O6T; 81701O6U; 81721O96; 81771OCH; 82101OWJ; 82171P28; 82181P34; 82201P58; 82331PE9; 82381PGM; 82961QGO; 82961QGP; 83011QJ8; 83161QVI; 83371R7W; 83391RAC; 83521RMA; 90081RTH; 90141RY4; 90471SLL; 90471SLM; 90971T45; 91131U0P; 91131U0Q; 91311UAO; 91331UD5; 91341UFQ; 91391UI9; 91411UKJ; 92031VT8; 92031VT9; 92081VUS; 92081VUT; 92381WGS; 92661WYV; 92661WYW; 92661WYX; 92721X4I; 92721X4J; 92851XBI; 93201XW6; 93211XYS; 93291Y3U; 93491YF6; 93521YHM; 93571YKM; 00561ZM5; 00681ZRF; 00741ZW7; 011820P9; 013020WH; 0138212H; 015221AQ; 015321BP; 015321BQ; 017621PB; 017621PC; 0208227D; 022822I6; 024622UG; 02602316; 02642331; 029423O7; 030023RA; 03192416.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • Descripción del producto
    Angiotech***T-Lok Ecomony 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 - 11ga x 4" Bone Marrow Needle "J" Type; || 1 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 3" x 3" Sponges (4-Ply); 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; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - CSR Wrap; ***Catalog Number: BMET1104TL***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, customer_service@angio.com, www.angiotech.com. || Intended for the purpose of harvesting bone and/or bone marrow specimens.
  • 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