Events

Retiro De Equipo (Recall) de Device Recall Medline Strider Midi 4 Scooter

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 Medline Industries 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
    36171
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1523-06
  • Fecha de inicio del evento
    2006-07-20
  • Fecha de publicación del evento
    2006-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48123
  • 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
    scooter - Product Code INI
  • Causa
    The p&g; solo 60a electronic control unit on the midi scooters may overheat.
  • Acción
    Medline sent 'Voluntary Field Correction' letters dated 7/20/06 to the direct accounts on the same date, informing them that the Strider Midi 3 and Midi 4 scooters have an older version of the electronic control unit that may overheat, which Medline will replace with a newer version of the controller. Any questions were directed to 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST).

Device

Device Recall Medline Strider Midi 4 Scooter
  • Modelo / Serial
    model MDS807550 - red and model MDS807550B - blue, Scooter no., controller no.:EV10DA-*US00108*,23010640; EV10DA-*US00113*,33010241; EV10DA-*US00121*,33010242; EV10DA-*US00127*,33010243; EV10DA-*US00117*,33010244; EV10DA-*US00112*,33010245; EV10DA-*US00129*,33010806; EV10DA-*US00123*,43010239; EV10DA-*US00119*,43010240; EV10DA-*US00118*,43010241; EV10DA-*US00120*,43010242; EV10DA-*US00116*,43010243; EV10DA-*US00128*,43010813; EV10DA-*US00125*,53010812; EV10DA-*US00122*,53010813; EV10DA-*US00130*,53011070; EV10DA-*US00148*,53050909; EV10DA-*US00152*,53050910; EV10DA-*US00155*,53050911; EV10DA-*US00146*,53050912; EV10DA-*US00153*,53050913; EV10DA-*US00110*,53050937; EV10DA-*US00101*,53050938; EV10DA-*US00126*,73010717; EV10DA-*US00147*,73050724; EV10DA-*US00150*,73050725; EV10DA-*US00145*,73050726; EV10DA-*US00149*,73050727; EV10DA-*US00151*,73050728; EV10DA-*US00103*,73050748; EV10DA-*US00109*,73050749; EV10DA-*US00136*,73050750; EV10DA-*US00102*,73050786; EV10DA-*US00106*,73050787; EV10DA-*US00107*,73050788; EV10DA-*US00111*,73050789; EV10DA-*US00115*,73050790; EV10DA-*US00105*,73050791; EV10DA-*US00135*,73050792; EV10DA-*US00137*,73050793; EV10DA-*US00139*,73050794; EV10DA-*US00141*,73050795; EV10DA-*US00142*,73050796; EV10DA-*US00138*,73050797; EV10DA-*US00143*,73050798; EV10DA-*US00133*,73050799; EV10DA-*US00140*,73050800; EV10DA-*US00132*,73050811; EV10DA-*US00131*,73060001; EV10DA-*US00160*,43010614; EV10DA-*US00159*,53010814; EV10DA-*US00157*,53010866; EV10DA-*US00158*,53011075; EV10DA-*US00156*,73010768; EV10DA-*US00162*,33010606; EV10DA-*US00165*,43010805; EV10DA-*US00163*,53010637; EV10DA-*US00167*,D49840/3 73010564; EV10DA-*US00221*,13010485; EV10DA-*US00225*,23010490; EV10DA-*US00223*,53010638; EV10DA-*US00222*,73010565; EV10DA-*UK00221*,43010782; EV10DA-*UK00227*,43010736; EV10DA-*UK00228*,43010733; EV10DA-*UK00232*,33010755; EV10DA-*UK00236*,33010797; EV10DA-*UK00240*,53011045; EV10DA-*UK00242*,73010819; EV10DA-*UK00248*,13010491; EV10DA-*UK00249*,53010926; EV10DA-*UK00257*,53010925; EV10DA-*UK00260*,53010923; EV10DA-*UK00266*,53010927; EV10DA-*UK00269*,53010830; EV10DA-*UK00271*,43010586; EV10DA-*UK00272*,53010829; EV10DA-*UK00275*,33010573; EV10DA-*UK00292*,53010861; EV10DA-*UK00310*,53011092; EV10DA-*UK00311*,53011085; EV10DA-*UK00315*,33020062; EV10DA-*UK00320*,53020055; EV10DA-*UK00321*,73010881; EV10DA-*UK00325*,73010563; EV10DA-*UK00336*,23010487; EV10DA-*UK00339*,13010481; EV10DA-*UK00345*,73010684; EV10DA-*UK00353*,73010688; EV10DA-*UK00357*,53010784; EV10DA-*UK00370*,53010634; EV10DA-*UK00373*,53010904; EV10DA-*UK00381*,43010587; EV10DA-*UK00383*,33010645; EV10DA-*UK00385*,73010798; EV10DA-*UK00409*,33010676; EV10DA-*UK00416*,43010680; EV10DA-*UK00420*,33010643; EV10DA-*UK00428*,73010703; EV10DA-*UK00432*,73010702; EV10DA-*UK00435*,53010844; EV10DA-*UK00448*,53010870; EV10DA-*UK00449*,13010496; EV10DA-*UK00459*,73010922; EV10DA-*UK00729*,53010726; EV10DA-*UK00733*,43010644; EV10DA-*UK00737*,43010648; EV10DA-*UK00748*,33010639; EV10DA-*UK00777*,43010692; EV10DA-*UK01382*,53050664; EV10DA-*UK01421*,43050439; EV10DA-*UK01516*,43050568; EV10DA-*UK01567*,73050340; EV10DA-*UK01570*,53050749; EV10DA-*UK01580*,33050609; EV10DA-*UK01582*,53050748; EV10DA-*UK01583*,73050568; EV10DA-*UK01589*,53050757; EV10DA-*UK01590*,73050563; EV10DA-*UK01593*,73050566; EV10DA-*UK01595*,43050625; EV10DA-*UK01599*,53050758; EV10DA-*UK01601*,43050624; EV10DA-*UK01603*,73050576; EV10DA-*UK01611*,33050640; EV10DA-*UK01612*,73050501; EV10DA-*UK01616*,33050638; EV10DA-*UK01626*,43050639; EV10DA-*UK01640*,43050427; EV10DA-*UK01641*,73050376; EV10DA-*UK01645*,53050545; EV10DA-*UK01651*,33050437; EV10DA-*UK01652*,33050425; EV10DA-*UK01656*,73050379; EV10DA-*UK01657*,53050544; EV10DA-*UK01658*,43050438; EV10DA-*UK01661*,53050566; EV10DA-*UK01662*,73050356; EV10DA-*UK01665*,33050426; EV10DA-*UK01666*,73050377; EV10DA-*UK01669*,53050659; EV10DA-*UK01672*,73050309; EV10DA-*UK01673*,33050642; EV10DA-*UK01679*,73050471; EV10DA-*UK01680*,53050661; EV10DA-*UK01683*,73050308; EV10DA-*UK01686*,33050625; EV10DA-*UK01687*,73050472; EV10DA-*UK01688*,53050495; EV10DA-*UK01689*,73050307; EV10DA-*UK01690*,53050494; EV10DA-*UK01695*,73050306; EV10DA-*UK01700*,73050310; EV10DA-*UK01701*,73050579; EV10DA-*UK01703*,53050820; EV10DA-*UK01708*,53050761; EV10DA-*UK01711*,53050786; EV10DA-*UK01713*,73050492; EV10DA-*UK01716*,53050679; EV10DA-*UK01719*,53050764; EV10DA-*UK01721*,53050668; EV10DA-*UK01722*,43050635; EV10DA-*UK01745*,53050787; EV10DA-*UK01763*,43050840; EV10DA-*UK01766*,33050796; EV10DA-*UK01770*,33050773; EV10DA-*UK01776*,53050887; EV10DA-*UK01778*,53050884; EV10DA-*UK01779*,73050734; UK01421, D50574.02 AU04101795
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mudelein, IL 60060 USA; model MDS807550 - red and MDS807550B - blue
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA