Events

Retiro De Equipo (Recall) de Device Recall MMS

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 MMS Sales Corp.

¿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
    31451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0760-05
  • Fecha de inicio del evento
    2005-02-21
  • Fecha de publicación del evento
    2005-04-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37920
  • 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
    Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
  • Causa
    Partial occlusion in the t-piece resulting in airway obstruction.
  • Acción
    The firm initiated the recall on February 21, 2004 by letter to all consignees.

Device

Device Recall MMS
  • Modelo / Serial
    Item Number 15867, 15 per case, Lot numbers: 562960904; 566590904;  Item Number 15880, 15 per case, Lot numbers: 564360904, 566230904, 570181004, 571831004, 573201004, 573201004, 575401104, 575401104, 577011104, 577011104, 578951104, 581731104, 582631204, 588431204, 588431204, 589090105, 591180105, 591180105, 593360105, 596220105, 596220105, 597890105, 597890105;  Item Number 12000-1, 7 per case, Lot Numbers: 581041104;  Item Number 15880-30, 15 per case, Lot Numbers: 573401004;  Item Number 40000-1, 20 per case, Lot Numbers: 568891004, 571691004, 581071104, 585381204, 589170105, 591260105, 593990105, 594930105;  Item Number 40200-1, 20 per case, Lot Numbers: 573461004, 573771004, 579661104;  Item Number 40301-1, 20 per case, Lot Numbers: 584241204;  Item Number 40301-1-13, 20 per case, Lot Numbers: 566290904, 569631004, 572811004, 574881104, 574881104, 578021104, 579671104, 585121204, 586721204, 588541204, 591330105, 593810105, 593810105;  Item Number 40301-1-13MM, 20 per case, Lot Numbers: 569211004, 583381204;  Item Number 40301-1-24, 20 per case, Lot Numbers: 564930904, 566300904, 571471004, 572821004, 574891104, 578081104, 580591104, 581691104, 583391204, 586731204, 588551204, 598410105;  Item Number 40301-1-30, 20 per case, Lot Numbers: 570781004, 593640105;  Item Number 40301-1ML, 20 per case, Lot Numbers: 574901104, 594840105;  Item Number 40302-1C24, 20 per case, Lot Numbers: 562980904, 566650904, 570791004;  Item Number 60000-1, 15 per case, Lot Numbers: 591360105;  Item Number 60201-1, 15 per case, Lot Numbers: 566370904, 568921004, 572491004, 573991004, 579691104, 581721104, 586761204, 590200105, 593860105, 595720105;  Item Number 60300-1, 15 per case, Lot Numbers: 594760105;  Item Number 60300-M, 15 per case, Lot Numbers: 568501004, 575711104;  Item Number 60301-1-24, 15 per case, Lot Numbers: 581731104;   Item Number 60301-13042M, 15 per case, Lot Numbers: 564510904, 568511004, 571951004, 573311004, 577181104, 580111104, 584431204, 586601204, 588621204, 589360105, 593490105, 596320105;   Item Number 60302-1HM30-70, 15 per case, Lot Numbers: 565830904, 581791104, 585661204, 589370105, 590210105;  Item Number 72000-50-7589, 15 per case, Lot Numbers: 583451204;  Item Number 72000-75, 15 per case, Lot Numbers: 568521004, 571511004, 571961004, 574971104, 577191104, 578131104, 578131104, 582761204, 584961204, 593870105;  Item Number 72300-1-4-30-70, 15 per case, Lot Numbers: 564950904, 567821004, 572841004, 578141104, 580621104, 583471204, 586771204, 589380105, 591430105, 593880105, 597180105;  Item Number 72301-1, 15 per case, 594880105;   Item Number C4N000D001, 20 per case, 568751004, 574801104, 578781104, 586301204, 591060105, 593660105, 595620105, 596830105, 596950105  Item Number 60301-1304042, 15 per case, Lot Number 597570105
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • Descripción del producto
    Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.
  • Manufacturer
    MMS Sales Corp

Manufacturer

MMS Sales Corp
  • Dirección del fabricante
    MMS Sales Corp, 218 Highline Rd, Pharr TX 78577-9726
  • Source
    USFDA