Events

Retiro De Equipo (Recall) de Convenience Kit

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 Merit Medical Systems, 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
    30119
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0050-05
  • Fecha de inicio del evento
    2004-09-14
  • Fecha de publicación del evento
    2004-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35209
  • 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
    Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
  • Acción
    All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

Device

Convenience Kit
  • Modelo / Serial
    Part No. K07-00116AP, Lot Nos A340949, A346191. Part No. K09-00302FP, Lot # A340485, A341488 Part No. K09-00579CP, Lot # A339214, A345673 Part No. K09-00585LP, Lot # A338201, A344694 Part No. K09-00759DP, Lot #A342359, A345674,   A347263. Part No. K09-00946MP, Lot # A341491 Part No. K09-00970K, Lot # A337245 Part No. K09-01574G, Lot # A343825 Part No. K09-01673H, Lot # A342676 Part No. K09-01908AP, Lot # A338729, A344187,   A344382. Part No. K09-02104HP, Lot # A337839, A346138 Part No. K09-02249H, Lot # A343819 Part No. K09-02249HP, Lot # A339688 Part No. K09-02334K, Lot # A345405 Part No. K09-02353G, Lot # A342675 Part No. K09-03242C, Lot # A342165 Part No. K09-03528D, Lot # A341710 Part No. K09-03978HP, Lot # A339229, A340896,  A344386. Part No.K09-04000HP, Lot # A338208, A339231,  A341504, A344612,  A341505, A341504. Part No. K09-04017C, Lot # A337857 Part No. K09-04316H, Lot # A342071. Part No. K09-04488A, Lot # A338228, A341118. Part No. K09-04863C, Lot # A337204, A338112. Part No. K09-04863C, Lot # A337204. Part No. K09-04923B, Lot # A340508, A 343196. Part No. K09-05138CP, Lot # A339425, A342802. Part No. K09-05229G, Lot # A339926. Part No. K09-05229GP, Lot # A345552. Part No. K09-05477A, Lot # A342803. Part No. K09-05785DP, Lot # A340897. Part No. K09-05939C, Lot # A337947, A342379. Part No. K09-05947D, Lot # A342670. Part No. K09-06262P, Lot # A341604. Part No. K09-07470C, Lot # A342173. Part No. K09-07547B, Lot # A340375. Part No. K09-07573AP, Lot # A344373. Part No. K09-07573P, Lot # A342349. Part No. K09-07589P, Lot # A347257, A347985. Part No. K09-07629CP, Lot # A344853. Part No. K09-07746A, Lot # A337319. Part No. K09-07759, Lot # A341614.  Part No. K09-07779P, Lot # A344855, A347876. Part No. K09-07847, Lot # A342385. Part No. K09-07883B, Lot # A336474. Part No. K09-07924AP, Lot # A346124. Part No. K09-07943AP, Lot # A345851. Part No. K09-07944A, Lot # A339427. Part No. K09-08020B, Lot # A331903. Part No. K09-08065P, Lot # A345570. Part No. K09-08150AP, Lot # A340352, A342387. Part No. K09-08214B, Lot # A340534 Part No. K09-08369, Lot # A342388. Part No. K09-08391AP, Lot # A340252, A343600. Part No. K09-08397, Lot # A335968. Part No. K09-90270KP, Lot # A3412623, A343596. Part No. K09-90358DP, Lot # A345692. Part No. K09-MS2366H, Lot # A341693. Part No. K09-MS2450B, Lot # A338759. Part No. K09-MS2550A, Lot # A343809. Part No. K09-MS2602A, Lot # A342813. Part No. K09-MS2638B, Lot # A341694, Part No. K09-MS2703B, Lot # A336929, A343808. Part No. K10-01223B, Lot # A339948. Part No. K10-03441P, Lot # A336328, A343551. Part No. K10-03616, Lot # A339959. Part No. K12-01176B, Lot # AS345883.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
  • Descripción del producto
    Convenience Kits containing Inject8 or Inject10 syringes.
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Dirección del fabricante
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA