Events

Retiro De Equipo (Recall) de Device Recall Taut Intraducer Peritoneal Catheter

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 Taut, 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
    37182
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0428-2007
  • Fecha de inicio del evento
    2007-01-19
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50062
  • 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
    Peritoneal Catheter - Product Code GBW
  • Causa
    Taut, inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
  • Acción
    Taut sent Urgent Medical Device Recall letters dated 1/19/07, via UPS over night, on the same date, informing them that the two lots of catheters may have package seals that are not intact. Customers were instructed to check their stocks for the affected lots, remove any found and return all affected product immediately. The PI-128 is also a component of the System One Comprehensive Lap CBDE Kist, catalog number 50000, which is a convenience kit. The customer is being instructed to remove the PI-128, Intraducer Peritoneal Catheter contained in the System Once Comprehensive Lap CBDE Kit in the eight kit lots listed, and return the PI-128 catheters. All other components of the kit may be used. As the PI-128, Intraducer Peritoneal Catheter, can also be ordered as a replacement component, the customer is also being instructed to check all opened System One Comprehensive lap CBDE kits, regardless of lot number, to ensure that it does not contain the impacted PI-128 lots. The customers were requested to complete and return the enclosed Acknowledgment & Stock Status Form, which includes an option to obtain replacement product for the PI-128, immediately faxing it back to Linda Todd at 919-433-4986. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Device Recall Taut Intraducer Peritoneal Catheter
  • Modelo / Serial
    catalog number (REF) PI-128, lot number 04116, use by 2008-01, and lot number 05178, use by 2008-09  These two lots of catheters were sold individually and as sterile components of catalog number (REF) 50000, kit lot numbers KC05107, KC05186, KC06002, KC06025, KC06071, KC06060, KC06087, KC06116
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Guam, Australia, Iceland and Italy
  • Descripción del producto
    Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: || a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and || b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit
  • Manufacturer
    Taut, Inc.

Manufacturer

Taut, Inc.
  • Dirección del fabricante
    Taut, Inc., 2571 Kaneville Ct, Geneva IL 60134-2505
  • Source
    USFDA