Events

Retiro De Equipo (Recall) de Custom Dialysis prep kits

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 Lee Medical International 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
    59877
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-3260-2011
  • Fecha de inicio del evento
    2011-08-15
  • Fecha de publicación del evento
    2011-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103919
  • 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
    Tray, start/stop (including contents), dialysis - Product Code FKG
  • Causa
    The firm used alcohol triple swabstick and prep pads manufactured by h & p industries in the manufacture of their custom dialysis kits. those swabsticks and pads were subsequently recalled due to possible bacterial contamination.
  • Acción
    The firm, Lee Medical International Inc., notified their consignees by email and telephone on August 17, 2011. Consignees were instructed to remove the affected product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.

Device

Custom Dialysis prep kits
  • Modelo / Serial
    ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B;  COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B;  COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B;  RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B;  SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A;  KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12;  METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12;  METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12;  MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.
  • Descripción del producto
    Custom Dialysis prep kits labeled as follows: || ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; || COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; || COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; || RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; || SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; || KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; || METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; || METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; || MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and || SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. || Product Usage: custom dialysis prep kits
  • Manufacturer
    Lee Medical International Inc

Manufacturer

Lee Medical International Inc
  • Dirección del fabricante
    Lee Medical International Inc, 612 Distributors Row, Harahan LA 70123-3206
  • Empresa matriz del fabricante (2017)
    Lee Medical International Inc.
  • Source
    USFDA