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  • Dispositivo 16
  • Fabricante 12
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1661-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109312
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1662-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109313
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1663-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109314
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1664-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109315
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Alerta De Seguridad para Zinqueno, known as Zinquenólica Pasta
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1665-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109316
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1666-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109317
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1667-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109318
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1668-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109319
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Alerta De Seguridad para Acrodent
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1669-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109321
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1670-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109322
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1671-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109323
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2012 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Retiro De Equipo (Recall) de Device Recall Curlin Infusion Administration Set
  • Tipo de evento
    Recall
  • ID del evento
    61895
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1672-2012
  • Fecha de inicio del evento
    2012-05-18
  • Fecha de publicación del evento
    2012-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109324
  • 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
    Tubing, fluid delivery - Product Code FPK
  • Causa
    Moog medical device group became aware on march 23, 2011 via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended.
  • Acción
    The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.
Alerta De Seguridad para 4-0 Nylon Suture Thread, single absorbable 12PCS Sterilized Surgical Sut...
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Stryker GoBed II
  • Tipo de evento
    Recall
  • ID del evento
    61712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1860-2012
  • Fecha de inicio del evento
    2012-05-17
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109325
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    An adverse trend of scale and bed exit service reports/complaints were detected for the gobed+, gobed ii, rose, and ma204 model beds. investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. the scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac.
  • Acción
    The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).
Retiro De Equipo (Recall) de Device Recall Stryker Rose Bed
  • Tipo de evento
    Recall
  • ID del evento
    61712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1861-2012
  • Fecha de inicio del evento
    2012-05-17
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109326
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    An adverse trend of scale and bed exit service reports/complaints were detected for the gobed+, gobed ii, rose, and ma204 model beds. investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. the scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac.
  • Acción
    The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).
Retiro De Equipo (Recall) de Device Recall Stryker MA204
  • Tipo de evento
    Recall
  • ID del evento
    61712
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1862-2012
  • Fecha de inicio del evento
    2012-05-17
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109327
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    An adverse trend of scale and bed exit service reports/complaints were detected for the gobed+, gobed ii, rose, and ma204 model beds. investigation found an abnormally high failure rate of loadcells, an integral component in scale and bed exit function. the scale faults are manifested as a fluctuating scale reading, a scale error causing the scale system to be disabled until serviced, or an inac.
  • Acción
    The firm, Stryker Medical, sent an "URGENT- Medical Device Correction" letter dated May 17, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to observe the beds for any malfunctions according to Preventive Maintenance Checklists in maintenance manual; report scale or bed exit malfunctions to Stryker (1-800-327-0770, option 2) to arrange for field service or to order service parts, at no charge. The customers were also instructed to forward this notice and advise Stryker of any subaccounts if the product was further distributed. A postage paid return postcard is to be filled for tracking and to make arrangements for repair. If you have any urgent questions or concerns, call 269-389-6466, Monday-Friday 8a.m-5p.m. (ET).
Retiro De Equipo (Recall) de Device Recall Econolux
  • Tipo de evento
    Recall
  • ID del evento
    61899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1857-2012
  • Fecha de inicio del evento
    2012-05-14
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109341
  • 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
    Gauze/sponge,nonresorbable for external use - Product Code NAB
  • Causa
    Micro holes were detected in the laminate of the sterile barrier system of sterilized hartmann econolux and hartmann sterilux gauze products.
  • Acción
    The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.
Alerta De Seguridad para PIP Breast Prosthesis
  • Tipo de evento
    Safety alert
  • País del evento
    Cuba
  • Fuente del evento
    HMC
  • URL de la fuente del evento
    https://www.cecmed.cu/vigilancia/equipos-medicos/alertas
  • Notas / Alertas
    Cuban data is current through 2018. All of the data comes from the Health Ministry of Cuba, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Cuba.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Device Recall Sterilux
  • Tipo de evento
    Recall
  • ID del evento
    61899
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1858-2012
  • Fecha de inicio del evento
    2012-05-14
  • Fecha de publicación del evento
    2012-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109342
  • 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
    Gauze/sponge,nonresorbable for external use - Product Code NAB
  • Causa
    Micro holes were detected in the laminate of the sterile barrier system of sterilized hartmann econolux and hartmann sterilux gauze products.
  • Acción
    The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.
Retiro De Equipo (Recall) de Device Recall Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2"
  • Tipo de evento
    Recall
  • ID del evento
    61908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1694-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109367
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • Acción
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
Retiro De Equipo (Recall) de Device Recall Monoject Insulin Safety Syringe 3/10mL 30 X 5/16"
  • Tipo de evento
    Recall
  • ID del evento
    61908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1695-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109368
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • Acción
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
Retiro De Equipo (Recall) de Device Recall Monoject Insulin Safety Syringe 1/2mL 29 X 1/2"
  • Tipo de evento
    Recall
  • ID del evento
    61908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1696-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109369
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • Acción
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
Retiro De Equipo (Recall) de Device Recall Monoject Insulin Safety Syringe 1/2mL 30 X 5/16"
  • Tipo de evento
    Recall
  • ID del evento
    61908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1697-2012
  • Fecha de inicio del evento
    2012-05-21
  • Fecha de publicación del evento
    2012-05-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109371
  • 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
    Syringe, piston - Product Code FMF
  • Causa
    Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick.
  • Acción
    Covidien sent an Urgent Product Recall letter dated May 21, 2012, via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using any affected product. Distributors were requested to notify their customers. Customers were instructed to complete the Monoject Insulin Safety Syringe recalled product return form even if they have no product to return. The form should be faxed to 1-800-895-6140 or e-mailed to sdfeedback@covidien.com. Customer Service questions regarding the recall please use one of the following methods. Telephone:1-800-722-8772 option I (Weekdays, 8am to 6:30pm Eastern) e-mail:sdfeedback@covidien.com
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.