• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Retiro De Equipo (Recall) de Newport e360 Ventilator
  • Tipo de evento
    Recall
  • ID del evento
    58620
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2468-2011
  • Fecha de inicio del evento
    2009-10-27
  • Fecha de publicación del evento
    2011-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99720
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    Cregarding e360 ventilators that were shipped with a different software version from what the customers ordered.
  • Acción
    Newport Medical Instruments Inc. initiated a field correction on October 27, 2009, to address complaints received regarding e360 ventilators that were shipped with a different software version from what the customers ordered. Newport Medical Instruments provided the correct software to the Newport sales or service providers who were responsible for the units affected. They installed the correct software into the ventilators at the customer sites. No written Correction Notice was provided since the corrections were done at the customers' request. Should you have any questions or require additional information, please call (714) 427-5811 extension 344.
Retiro De Equipo (Recall) de Newport HT70 Ventilator
  • Tipo de evento
    Recall
  • ID del evento
    58619
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2406-2011
  • Fecha de inicio del evento
    2010-09-20
  • Fecha de publicación del evento
    2011-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99719
  • 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
    Ventilator, continuous facility use. - Product Code CBK
  • Causa
    The recall was initiated because newport medical has confirmed a limited number of power cords recently received from their supplier, glob-tek, have a slightly oversized plug connector which prevents the cord from locking into place. these cords are fully functional as supplied. however, the cord can be easily disconnected. if the cord is disconnected, the ht70 will alert the user with a power di.
  • Acción
    Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord. Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.
Retiro De Equipo (Recall) de MAKO PN 204588 Camera
  • Tipo de evento
    Recall
  • ID del evento
    58464
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2232-2011
  • Fecha de inicio del evento
    2010-10-25
  • Fecha de publicación del evento
    2011-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99406
  • 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
    Camera, surgical and accessories - Product Code KQM
  • Causa
    Mako surgical corporation recalled one infra-red camera mako pn 204854 which was a component of their rio robotic arm interactive orthopedic system with ssn p7-03127, on november 22, 2010. this component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. the recall was initiated after the camera manufacture, ndi, waterloo, on.
  • Acción
    The firm, MAKO, sent a "RECALL NOTICE" letter dated November 22, 2010, to its customer. The letter described the product, problem and action to be taken. The customer was instructed to complete and return the attached Acknowledgement Form to their MAKOplasty Specialist (MPS) via mail to: MAKO Surgical Corp., Attn: Jim Pomeroy, 2555 Davie Road, Fort Lauderdale, FL 33317. The letter stated that "It is important that the camera be replaced immediately, and MAKO is currently addressing the situation with the camera manufacturer." In addition, MAKO will replace the camera with a camera that is not affected by the recall and verify the customers system to meet the functional specifications. If you have any questions or concerns, please contact your MPS or Sr. Director of Quality Assurance at 954-927-2044 ext 604, and /or Sr. Director, Customer Support at 954-927-2044 ext. 442.
Retiro De Equipo (Recall) de TAPSCOPE 550
  • Tipo de evento
    Recall
  • ID del evento
    58302
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0071-2012
  • Fecha de inicio del evento
    2010-10-25
  • Fecha de publicación del evento
    2011-10-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98932
  • 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
    System, esophageal pacing - Product Code LPA
  • Causa
    Cardiocommand, inc. is recalling their tapscope 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ecg.
  • Acción
    On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.
Retiro De Equipo (Recall) de Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfectio...
  • Tipo de evento
    Recall
  • ID del evento
    57232
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1734-2011
  • Fecha de inicio del evento
    2010-09-23
  • Fecha de publicación del evento
    2011-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97577
  • 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
    Microtome, cryostat - Product Code IDP
  • Causa
    Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
  • Acción
    ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.
Retiro De Equipo (Recall) de Monaco Radiation Treatment Planning Workstation
  • Tipo de evento
    Recall
  • ID del evento
    57843
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2569-2011
  • Fecha de inicio del evento
    2010-10-27
  • Fecha de publicación del evento
    2011-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97545
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • Causa
    Monaco: in xio imrt (dynamic mlc delivery) software, the radiation beam angle is set to zero. if different beam angles are selected via monaco software, the beam angles will remain at zero.
  • Acción
    Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
Retiro De Equipo (Recall) de Neotrode, Softrade, TruLink
  • Tipo de evento
    Recall
  • ID del evento
    57827
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1493-2011
  • Fecha de inicio del evento
    2010-09-23
  • Fecha de publicación del evento
    2011-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97513
  • 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
    ecg electrode - Product Code DRX
  • Causa
    Poor signal or loss of signal. certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
  • Acción
    ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.
Retiro De Equipo (Recall) de 115V Blanketroll III Model 233 and 115V CoolBlue Model 2501
  • Tipo de evento
    Recall
  • ID del evento
    57004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1817-2011
  • Fecha de inicio del evento
    2010-10-18
  • Fecha de publicación del evento
    2011-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97410
  • 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
    Thermal Regulating System - Product Code DWJ
  • Causa
    The firm initiated this recall due to changes that have been made to the blanketrol iii model 233 device's operation and operation/technical service manuals, in order to stay in compliance with labeling regulations.
  • Acción
    On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to B3manual@cszinc.com. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.
Retiro De Equipo (Recall) de OmniDiagnost Eleva
  • Tipo de evento
    Recall
  • ID del evento
    57777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1657-2011
  • Fecha de inicio del evento
    2010-10-07
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97394
  • 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
    x-ray system - Product Code IZI
  • Causa
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Acción
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Retiro De Equipo (Recall) de MultiDiagnost Eleva
  • Tipo de evento
    Recall
  • ID del evento
    57777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1656-2011
  • Fecha de inicio del evento
    2010-10-07
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97393
  • 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
    x-ray system - Product Code IZI
  • Causa
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Acción
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Retiro De Equipo (Recall) de Allura Integris Systems with OMCP Generator
  • Tipo de evento
    Recall
  • ID del evento
    57777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1655-2011
  • Fecha de inicio del evento
    2010-10-07
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97392
  • 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
    x-ray system - Product Code IZI
  • Causa
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Acción
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Retiro De Equipo (Recall) de Allura Xper Systems with Velara Generator
  • Tipo de evento
    Recall
  • ID del evento
    57777
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1654-2011
  • Fecha de inicio del evento
    2010-10-07
  • Fecha de publicación del evento
    2011-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97385
  • 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
    x-ray system. - Product Code IZI
  • Causa
    A wire in the connector of the generator grid switch supervisor box might short-circuit between 12v power and ground, and it will cause a system breakdown.
  • Acción
    On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.
Retiro De Equipo (Recall) de Unicel DXC and SYNCHRON LX Clinical Systems
  • Tipo de evento
    Recall
  • ID del evento
    57779
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2070-2011
  • Fecha de inicio del evento
    2010-10-22
  • Fecha de publicación del evento
    2011-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97384
  • 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
    Electrode, ion specific, potassium - Product Code JGS
  • Causa
    This recall was initiated because beckman coulter has confirmed that for user-defined chemistries (udrs), the polychrome correction is not automatically updated when wavelengths are modified.
  • Acción
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel¿¿ DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1218-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97328
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1217-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97327
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1216-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97326
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1215-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97325
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1214-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97324
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1213-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97323
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1212-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97322
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1211-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97321
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1210-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97320
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Five L...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1209-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97282
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiot...
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1208-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97281
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Retiro De Equipo (Recall) de Central Venous Catheter Tray Five Lumen Polyurethane
  • Tipo de evento
    Recall
  • ID del evento
    57663
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1207-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97280
  • 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
    Peripherally Inserted, Central Venous Catheter Tray - Product Code FOZ
  • Causa
    Cook, inc. is recalling single, double, triple, and five-lumen central venous catheter trays and single and double lumen picc peripherally inserted central venous catheter trays. these kits and trays contain 0.9% sodium chloride injection usp 5 ml fill in 6 ml flush syringes that have been recalled by excelsior medical. during a routine test for syringe sterility, a possible integrity failure wa.
  • Acción
    Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

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.