Events

Retiro De Equipo (Recall) de Medex Closed Blood Sampling kits and pressure monitoring sets which contain the blood sampling port.

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 Medex 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
    30268
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0198-05
  • Fecha de inicio del evento
    2004-10-20
  • Fecha de publicación del evento
    2004-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35588
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Causa
    Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
  • Acción
    The firm sent certified letters on October 20 & 21, 2004 to all customers to whom the product was sent directly and to all distributors to whom Medex shipped the product directly in the United States. Customers in foreign countries were notified via Fed Ex.

Device

Medex Closed Blood Sampling kits and pressure monitoring sets which contain the blood sampling port.
  • Modelo / Serial
    MX20170: Lot #s 33D160090, 33J100011,34A12D017, 34D28D092.  MX20443: Lot #s 32J240054, 32K140054, 32L110056, 32L260051, 33A160015, 33B120027, 33B260040, 33C200060, 33D090064, 33D230066, 33E210102, 33E290113, 33F110010, 33G240058, 33H080024, 33I040010, 33J020029, 33J160008, 33J230033, 33K120027, 33L030054, 34B04D092, 34B16D019, 34B26D023, 34C11D001.   MX20470: Lot 34A22D075.  MX20477: Lot #s 33D020091, 33K120026.  MX20730: Lot #s 33C050084, 33D110030, 33E010093, 33F030094, 33G030104, 34A12D137, 34C31D055.  MX20760: Lot #''s 33C270065, 33I230822, 33K100055, 33K240050, 34A12D082, 34B26D099, 34C04D029.   MX20822: Lot #''s 33I090048, 34A22D110.  MX4033: Lot #''s 32L120073, 33A06143, 33A080077, 33B040079, 33C040104, 33C270062, 33D250039, 33E050044, 34B02D072, 34C08D038.  MX4037: Lot #''s 33A080069, 33B110006, 33C270063, 33D220026, 33F020063, 33G080019, 33G230005, 33J140016, 34A26D108, 34C08D034.  MX700376: Lot 33A2220390.  MX700377: Lot #''s 33A2220392, 33A2920402.   MX7781R1: Lot #''s 32L040106, 33H080048.  MX8004CSTT: Lot 33K140086.   MX8033T: Lot #''s 32L040021, 33B040050, 33H220097, 34B03D044.  MX9502CSTT: Lot #''s 32K150075, 33A310026, 33G150105, 33K250018, 34B04D014.  MX9504CSTT: Lot #''s 32J250089, 32L050045, 33A240034, 33B130060, 33C060003, 33D280078, 33F040042, 33H140037, 33H200018, 34A26D097.  MX9505CSTT: Lot #''s 33D2322860, 34C22D067.   MX9506CSTT: Lot 33L020058.  MX9533T: Lot #''s 32K260078, 33A090065, 33C140050, 33E290013, 33H070093, 33I090014, 33K040033, 33L020068, 34A26D098, 34B25D049, 34C30D034, 34D27D047.  MX9534T: Lot #''s 33A160085, 33B250064, 33D100061, 33F250042, 33H140048, 33J070023.   MX9537T: Lot #''s 33A090071, 33B250065, 33D230022, 33F100153, 33G090033, 33H070089, 33I020046, 33J070024, 33K180032, 34A15D040, 34B04D022, 34B16D081, 34C03D039.  MX9602CSTA: Lot #''s 32K150073, 33A240039, 33D160033, 33G090027, 33G230029.   MX9604CSTA: Lot #''s 33A240037, 33A310028, 33C140029, 33D100058, 33F040040, 33L190038.  MX9605CSTA: Lot #''s 32J310063, 32L270023, 33B250063, 33C140031, 33D100054, 33E290017, 33F100155, 33F250061, 33G300021, 33H140043, 33I300032, 33K180035, 33L190036, 34A26D089, 34B19D098.  MX9606CSTA: Lot #''s 32L050050, 33A090069, 33A310031, 33C060008, 33C200010, 33D230031, 33E130048, 33F250040, 33G230030, 33H140044, 33I170051, 33K040035, 33K250040, 34A12D037, 34A26D083, 34B16D083, 34C03D040.  MX9607CSTA: Lot #''s 32J300018, 33E050037, 33J280007, 34B02D043.  MX9634A: Lot #''s 33A160083, 33A310034, 33C200011, 33D100072, 33E280100, 33G230025, 33I170052, 33K180034, 33L190040, 34A26D099, 34B25D046.  MX9637A: Lot #''s 33A160084, 33B130050, 33D230021, 33E200059, 33F170096, 33K250042, 34A26D086, 34C03D036.  SX02: Lot 33G080023.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed throughout the United States to distributors and hospitals located in FL, PA, CA, NE, SC, NY, MO, NM, GA, IL, MN, NC, Washington DC, RI, CO, MS, WI, HI, TX, MI, VA, WA, NJ, KY, MA, LA, TN, AZ, MD, OR, PR, UT, TN, OH, AL, IN, NV, OK and to foreign accounts located in Mexico, TMP, Ecuador, Brazil, LKA, Thailand, New Zealand, Australia, and Canada.
  • Descripción del producto
    MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, || MX20443: LogiCal Single Pressure Kit, || MX20470: Pressure Monitoring Kit, || MX20477: LogiCal Double Kit, || MX20730: Double LogiCal Kit, || MX20760: Neonatal 18'' Add-On Kit, || MX20822: TranStar Monitoring Set, || MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, || MX4037: Kids Kit Add-On Blood Sampling Kit, || MX700376: TranStar Triple Monitoring Kit, || MX700377: Double TranStar Kit, || MX7781R1: St Judes Secure Kit, || MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, || MX8033T: Novatrans Kids Kit Neonatal Mtring, || MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, || MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, || MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, || MX9506CSTT: TranStar 72in Secure Triple Kit, || MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, || MX9534T: TranStar Kids Kit, || MX9537T: TranStar Kids Kit, || MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, || MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, || MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, || MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, || MX9607CSTA: LogiCal Triple Secure Kit, || MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, || MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, || SX02: Sterile Sample
  • Manufacturer
    Medex Inc

Manufacturer

Medex Inc
  • Dirección del fabricante
    Medex Inc, 6250 Shier Rings Rd, Dublin OH 43016-1270
  • Source
    USFDA