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  • Dispositivo 374
  • Fabricante 58
  • Evento 124969
  • Implante 1
Retiro De Equipo (Recall) de Device Recall 15 Drop IV Sets
  • Tipo de evento
    Recall
  • ID del evento
    54723
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1115-2010
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2010-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89066
  • 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
    Intravascular administration set - Product Code FPA
  • Causa
    Sterility may be compromised.
  • Acción
    The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Retiro De Equipo (Recall) de Device Recall NonVented IV Set with 2Gang "HiFlo" Stopcocks with Lu...
  • Tipo de evento
    Recall
  • ID del evento
    54723
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1116-2010
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2010-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89067
  • 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
    Intravascular administration set - Product Code FPA
  • Causa
    Sterility may be compromised.
  • Acción
    The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Retiro De Equipo (Recall) de Device Recall Positive Pressure Blood Pump Sets
  • Tipo de evento
    Recall
  • ID del evento
    54723
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1117-2010
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2010-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89068
  • 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
    Intravascular administration set - Product Code FPA
  • Causa
    Sterility may be compromised.
  • Acción
    The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Retiro De Equipo (Recall) de Device Recall P/N 302050 HANDI FIL DISPOSABLE SYRINGE FILL TUBE
  • Tipo de evento
    Recall
  • ID del evento
    54724
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2081-2012
  • Fecha de inicio del evento
    2010-02-01
  • Fecha de publicación del evento
    2012-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89069
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Causa
    A report was received from a japanese distributor regarding a complaint from a hospital customer stating that ten packages of handi fil were not sealed.
  • Acción
    Covidien send an Urgent Device Recall letter dated February 1, 2010, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and discontinue use of the product immediately. Customers were asked to complete the attached business form and report the quantity of affected product currently in their stock. Once the form is completed customers should fax the form to 314-654-8206. Once the business notification form is received, an RGA number will be sent to the customer for return of the product. Customers will receive credit for all returned product. For questions regarding this recall call the Product Monitoring Department at 800-778-7898. For questions about credit for the product, please call Customer Service at 888-774-1414, menu option 1, then menu option 2. For questions regarding this recall call 513-948-5719.
Retiro De Equipo (Recall) de Device Recall Mini MaxTorque HCS05632 Drivers
  • Tipo de evento
    Recall
  • ID del evento
    54725
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0026-2013
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2012-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89070
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    The tips of the drivers are breaking while being used to drive the screws into patients.
  • Acción
    The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
Retiro De Equipo (Recall) de Device Recall Mini MaxTorque HCS05632 Drivers
  • Tipo de evento
    Recall
  • ID del evento
    54725
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0027-2013
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2012-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89071
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    The tips of the drivers are breaking while being used to drive the screws into patients.
  • Acción
    The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
Retiro De Equipo (Recall) de Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOA...
  • Tipo de evento
    Recall
  • ID del evento
    54729
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1318-2010
  • Fecha de inicio del evento
    2010-02-06
  • Fecha de publicación del evento
    2010-04-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89075
  • 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
    immunoassay method, troponin subunit - Product Code MMI
  • Causa
    The recall was initiated because beckman coulter has confirmed customer reports that different results have been obtained using the same patient samples on access/access 2 and unicel dxl platforms. values obtained with unicel dxl systems have been demonstrated to have a positive bias compared to values obtained with access or access 2 systems.
  • Acción
    An "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM. If consignees need assistance or have any questions regarding the notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.
Retiro De Equipo (Recall) de Device Recall Harmony LA 500
  • Tipo de evento
    Recall
  • ID del evento
    54742
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1218-2010
  • Fecha de inicio del evento
    2010-02-23
  • Fecha de publicación del evento
    2010-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89088
  • 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
    Lamp, surgical - Product Code FTD
  • Causa
    Premature bulb failure.
  • Acción
    STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.
Retiro De Equipo (Recall) de Device Recall Harmony LA 700
  • Tipo de evento
    Recall
  • ID del evento
    54742
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1219-2010
  • Fecha de inicio del evento
    2010-02-23
  • Fecha de publicación del evento
    2010-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89089
  • 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
    Lamp, surgical - Product Code FTD
  • Causa
    Premature bulb failure.
  • Acción
    STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.
Retiro De Equipo (Recall) de Device Recall Harmony LC 500
  • Tipo de evento
    Recall
  • ID del evento
    54742
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1220-2010
  • Fecha de inicio del evento
    2010-02-23
  • Fecha de publicación del evento
    2010-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89090
  • 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
    Lamp, surgical - Product Code FTD
  • Causa
    Premature bulb failure.
  • Acción
    STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.
Retiro De Equipo (Recall) de Device Recall Dimension Vista Chemistry 2 Calibrator
  • Tipo de evento
    Recall
  • ID del evento
    54743
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2387-2010
  • Fecha de inicio del evento
    2010-02-26
  • Fecha de publicación del evento
    2010-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89091
  • 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
    Multi-Analyte Mixture Calibrator - Product Code JIX
  • Causa
    There is incorrect barcode information, which can potentially cause the alert message "calibrator insert missing" to be displayed.
  • Acción
    The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.
Retiro De Equipo (Recall) de Device Recall BioRad Variant II Turbo Link Hemoglobin Testing System
  • Tipo de evento
    Recall
  • ID del evento
    54746
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1259-2011
  • Fecha de inicio del evento
    2010-02-19
  • Fecha de publicación del evento
    2011-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89093
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Causa
    The results from the blood device had the occurrence of some ramping baselines on their chromatograms. the ramping baseline can affect quantitation of the blood results.
  • Acción
    The firm, Bio-Rad Laboratories, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 5, 2010, to all customers and letter dated February 16, 2010 to subsidiaries via Fed-Ex or by fax. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review there chromatograms form the lots listed and compare them to what documented; follow the noted instructions; destroy reorder packs from the affected lots if a ramping baseline issue is observed, and complete and return the attached CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM via fax to (510) 741-3954, attention: Bio-Rad CSD Regulatory Affairs Department. If you have any questions, please contact your regional Bio-Rad Office or (510)724-7000.
Retiro De Equipo (Recall) de Device Recall Hemochron Signature Elite Whole Blood Microcoagulatio...
  • Tipo de evento
    Recall
  • ID del evento
    54768
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0893-2011
  • Fecha de inicio del evento
    2010-03-31
  • Fecha de publicación del evento
    2011-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89130
  • 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
    Upc Reader (bar code reader) - Product Code RFZ
  • Causa
    There is a mismatch between the class of the laser barcode scanner and the labeling of the hemochron signature elite: some of the devices were inadvertently equipped with class ii laser barcode scanner instead of the intended class i barcode scanner.
  • Acción
    Urgent - Medical Device Recall - Hemochron Signature Elite letters, dated February 24, 2010, by Federal Express to all direct customers. The letter informed customers of the issue and stated that the problem does not negatively affect the performance of the product and to continue using the product as intended. In addition, customers are to notify the appropriate personnel about the notice, complete and return the attached form, and an ITC representative will contact customers to discuss arrangements to re-label their devices. Customers can contact ITC Technical Support at 800-579-2255 (US) or 732-548-5700 ext 4700 (International) if they have any questions regarding this issue and notice. Customers can also email sigelitescan@itcmed.com with questions.
Retiro De Equipo (Recall) de Device Recall Integra Licox
  • Tipo de evento
    Recall
  • ID del evento
    54769
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1422-2010
  • Fecha de inicio del evento
    2010-02-18
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89131
  • 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
    brain oxygen probe - Product Code GWM
  • Causa
    One probe that had failed a product release test was inadvertently packaged and released into inventory in integra's distribution center.
  • Acción
    An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Surgical Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1414-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89138
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de Device Recall ExactaMix TM Valve Set
  • Tipo de evento
    Recall
  • ID del evento
    54773
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1197-2010
  • Fecha de inicio del evento
    2010-02-10
  • Fecha de publicación del evento
    2010-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89139
  • 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
    Set, i.v. fluid transfer - Product Code LHI
  • Causa
    Molding defect in the valve body causes leaking.
  • Acción
    Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.
Retiro De Equipo (Recall) de Device Recall Acuson Antares Utrasound imaging device
  • Tipo de evento
    Recall
  • ID del evento
    54844
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1853-2011
  • Fecha de inicio del evento
    2010-03-01
  • Fecha de publicación del evento
    2011-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89308
  • 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
    Utrasound imaging device - Product Code IYN
  • Causa
    Image captured from the device may be erroneous.
  • Acción
    Acuson Customer Safety Advisory notification letters were sent March 1, 2010 by certified mail.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Paper Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1415-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89140
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Paper Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1416-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89141
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Paper Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1417-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89143
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Paper Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1418-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89144
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de DePuy Spine Bremer Halo System
  • Tipo de evento
    Recall
  • ID del evento
    36504
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0134-2007
  • Fecha de inicio del evento
    2006-10-10
  • Fecha de publicación del evento
    2006-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48760
  • 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
    halo system - Product Code HWC
  • Causa
    Sterility of device is compromised due to loss of package integrity.
  • Acción
    DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.
Retiro De Equipo (Recall) de Device Recall 3M Micropore Paper Tape
  • Tipo de evento
    Recall
  • ID del evento
    54640
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1419-2010
  • Fecha de inicio del evento
    2010-01-29
  • Fecha de publicación del evento
    2010-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89146
  • 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
    Surgical Tape - Product Code KGX
  • Causa
    Reduced adhesion: micropore surgical tape for use as the primary securement device for 1) dialysis needles used to access a-v fistulas or grafts; or 2) pressure dressings used after dialysis treatments. if the tape does not perform, the dialysis needle may loosen and could then dislodge. in the interim, please offer 3m micropore surgical tape, 1 inch x 10 yard rolls (cat #1530-1) as a substitutio.
  • Acción
    An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Retiro De Equipo (Recall) de Device Recall UCG Slide Test
  • Tipo de evento
    Recall
  • ID del evento
    54745
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2500-2010
  • Fecha de inicio del evento
    2010-02-12
  • Fecha de publicación del evento
    2010-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89149
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Causa
    Specific lots no longer meet their stated limit of detection claims of 2000 miu/ml for the ucg-slide test and 500 miu/ml for the ucg-beta slide monoclonal ii test.
  • Acción
    The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
Retiro De Equipo (Recall) de Device Recall UCG BetaSlide Monoclonal II
  • Tipo de evento
    Recall
  • ID del evento
    54745
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2501-2010
  • Fecha de inicio del evento
    2010-02-12
  • Fecha de publicación del evento
    2010-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89150
  • 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
    Kit, Test, Pregnancy, Hcg, Over The Counter - Product Code LCX
  • Causa
    Specific lots no longer meet their stated limit of detection claims of 2000 miu/ml for the ucg-slide test and 500 miu/ml for the ucg-beta slide monoclonal ii test.
  • Acción
    The recall was initiated on February 12, 2010. Letters were sent by Fed Ex on 2/12/2010.
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