Retiro De Equipo (Recall) de Device Recall 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
    59692
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-3120-2011
  • Fecha de inicio del evento
    2011-03-22
  • Fecha de publicación del evento
    2011-09-07
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-01-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Firm manufactured custom dialysis kits with povidone iodine (pvp) prep pads which were recalled by h & p industries. those pads were subsequently recalled due to possible bacterial contamination.
  • Acción
    The firm, Lee Medical International Inc., notified their consignees by email and telephone on 03/22/2011. Consignees were instructed to pull 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

  • Modelo / Serial
    KIDNEYCARE, LOT #A1160, EXP 7-12  MESCALERO-HEMO, LOT #B1113, EXP 8-12  DAV-MT-POCONO-H, LOT #B1123, EXP 8-12  ADV-CATH-ISL44, LOT #B1127 EXP 8-12  ADV-HEMO-15G, LOT #B1128, EXP 8-  NORTHHUDSON-C, LOT #B1134, EXP 8-12  NORTHHUDSON-H, LOT #B1135, EXP 8-12   JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12  JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12  JOHNHAYES-SUB, SMALL GLOVES, LOT #B1148, EXP 8-12  JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12   SNCH-CATH, LOT #B1152, EXP 8-12   COMMUNITY-HEMO, LOT #B1156, EXP 8-12  FLAMS-HEMO, LOT #B1162, EXP 8-12   KINDEYSPA-HEMO, LOT #B1161, EXP 8-12  DAV-POCONO-H, LOT #C1107, EXP 9-12  DAV-POCONO-CATH, LOT #C1108, EXP 9-12  DAV-MT-POCONO-H, LOT #C1109, EXP 9-12  MESCALERO-HEMO, LOT #C1110, EXP 9-12  KIDNEYTRMT-HEMO, LOT #C1112 and C1123, EXP 9-12  DAV-POCONO-H, LOT #C1126, EXP 9-12  METHODIST-HEMO, LOT #C1139, EXP 9-12  KINGMAN-HEMO, LOT #C1141, EXP 9-12  DAV-PALMERTON-H, LOT #C1145, EXP 9-12  EMANUEL-CATH, LOT #C1146, EXP 9-12
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.
  • Descripción del producto
    Custom dialysis prep kits labeled as follows: || KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 || MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 || ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 || ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 || NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 || NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 || COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 || KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 || MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 || EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 || Product Usage: custom dialysis prep kits
  • Manufacturer

Manufacturer

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