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  • Dispositivo 960
  • Fabricante 297
  • Evento 124969
  • Implante 79
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2832-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157219
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2833-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157220
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2834-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157221
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2835-201
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157222
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2836-201
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157223
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1...
  • Tipo de evento
    Recall
  • ID del evento
    28428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0748-04
  • Fecha de inicio del evento
    2004-03-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31820
  • 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
    Blood Pressure Cuff - Product Code DXQ
  • Causa
    Gmp deficiencies.
  • Acción
    Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2837-201
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157224
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2838-201
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157225
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2839-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157226
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2840-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157227
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2841-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157228
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable ...
  • Tipo de evento
    Recall
  • ID del evento
    28428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0749-04
  • Fecha de inicio del evento
    2004-03-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31821
  • 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
    Blood Pressure Cuff - Product Code DXQ
  • Causa
    Gmp deficiencies.
  • Acción
    Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2842-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157229
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2843-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157230
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2844-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157231
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2845-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157233
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2846-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157234
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1...
  • Tipo de evento
    Recall
  • ID del evento
    28428
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0750-04
  • Fecha de inicio del evento
    2004-03-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31822
  • 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
    Blood Pressure Cuff - Product Code DXQ
  • Causa
    Gmp deficiencies.
  • Acción
    Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2847-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157235
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2848-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157236
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe and Hypodermic Needle
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2849-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157238
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2850-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157239
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall Piston Syringe
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2851-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157240
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.com.
Retiro De Equipo (Recall) de Device Recall TDx/TDxFLx
  • Tipo de evento
    Recall
  • ID del evento
    25220
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0691-03
  • Fecha de inicio del evento
    2002-12-11
  • Fecha de publicación del evento
    2003-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25409
  • 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 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 data.
  • Notas adicionales en la data
    unknown device name - Product Code 91
  • Causa
    Unexpected false positive tca results.
  • Acción
    A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
Retiro De Equipo (Recall) de Device Recall Piston Syringe
  • Tipo de evento
    Recall
  • ID del evento
    77658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2852-2017
  • Fecha de inicio del evento
    2017-06-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157241
  • 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
    Insufficient documentation to support product sterility claims.
  • Acción
    The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: quality@intlmedsurg.com; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: quality@intlmedsurg.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.