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  • Dispositivo 124
  • Fabricante 32
  • Evento 124969
  • Implante 6
Retiro De Equipo (Recall) de B.Braun Celsite
  • Tipo de evento
    Recall
  • ID del evento
    58718
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2671-2011
  • Fecha de inicio del evento
    2011-04-13
  • Fecha de publicación del evento
    2011-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100140
  • 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 access port - Product Code LJT
  • Causa
    The affected products contain the incorrect winged surecan¿ needle accessory component in certain celsite¿ access port package configurations. the winged surecan¿ needle is used to deliver medications and fluids into implanted celsite¿ access ports. two winged surecan¿ needle sizes are provided in celsite¿ u.S. package configurations: 20g (pn 4058631) or 22g (pn 16006593a). a 20g or 22g needle.
  • Acción
    B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers. The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite¿ Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite¿ Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist. For additional information contact 800 523-9676 x4459.
Retiro De Equipo (Recall) de SeraQuest CMV IgM
  • Tipo de evento
    Recall
  • ID del evento
    58551
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0837-2012
  • Fecha de publicación del evento
    2012-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100141
  • 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
    Antibody igm,if, cytomegalovirus virus - Product Code LKQ
  • Causa
    Quest international recalled their cmv igm test kit because the device failed the test run due to lack of activity in the coated wells.
  • Acción
    On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700. The memo identified the affected product and stated the problem with the device. The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately. Questions should be directed to 305-592-6991.
Retiro De Equipo (Recall) de CDI 500
  • Tipo de evento
    Recall
  • ID del evento
    58532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2678-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100189
  • 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 parameter monitoring system - Product Code DRY
  • Causa
    Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient. the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
  • Acción
    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
Retiro De Equipo (Recall) de CDI 500
  • Tipo de evento
    Recall
  • ID del evento
    58532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2679-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100193
  • 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 parameter monitoring system - Product Code DRY
  • Causa
    Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient. the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
  • Acción
    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
Retiro De Equipo (Recall) de Harleco Giemsa Stain
  • Tipo de evento
    Recall
  • ID del evento
    58746
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0043-2012
  • Fecha de inicio del evento
    2011-04-04
  • Fecha de publicación del evento
    2011-10-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100214
  • 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
    Stains, hematology - Product Code KQC
  • Causa
    Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.
  • Acción
    EMD Chemicals Inc. sent an "IMPORTANT PRODUCT RECALL" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. An attached response form is included for customers to complete and return via fax to EMD Chemicals at 856-423-6314. Any questions concerning this recall notice should be directed to EMD Chemicals Technical Service Department at 1-800-222-0342.
Retiro De Equipo (Recall) de Precision Ice
  • Tipo de evento
    Recall
  • ID del evento
    58770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2659-2011
  • Fecha de inicio del evento
    2011-04-18
  • Fecha de publicación del evento
    2011-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100276
  • 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
    Pack (hot/cold) water circulating - Product Code ILO
  • Causa
    The control panel of the precision ice one patient use control unit and wrap system has a overheating issue. the control panel printed circuit boards were missing a jumper connection across resistors r28 a, b, c, and d.
  • Acción
    Pro Trainers' Choice sent a Mandate-Medical Device Recall on April 18, 2011 and April 20, 2011 to all affected costumers. The letter included a description of the product, affected model and lots. It instructed the costumers to discontinue using the Precision Ice, Model 4BBK02BK until the device is returned and corrected by Pro Trainers' Choice. The device should be returned to PO Box 27, Kingston, WA 98346. The customers were instructed to notify their sub-account customers of this recall if the devices were further distributed. Customers can call Pro Trainers' Choice Company at 360-297-3902 or visit the website www.precisionice.com for any questions about this recall.
Retiro De Equipo (Recall) de CDITM 101 Monitor
  • Tipo de evento
    Recall
  • ID del evento
    58779
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2610-2011
  • Fecha de inicio del evento
    2011-04-28
  • Fecha de publicación del evento
    2011-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100288
  • 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
    monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Causa
    Terumo discovered through its own testing that the presence of electromagnetic interference (emi) in the operating room may affect the accuracy of the values displayed by the cdi"101 hematocrit/oxygen saturation monitoring system: hematocrit (hct), hemoglobin (hgb) and oxygen saturation.
  • Acción
    Terumo Cardiovascular Systems, Corp issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer. After a solution has been verified, Terumo CVS will implement a correction for all affected units. Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form. For further question please contact Terumo CVS Customer Service at 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST.
Retiro De Equipo (Recall) de COBAS AmpliPrep / COBAS TaqMan HCV Test, USIVD
  • Tipo de evento
    Recall
  • ID del evento
    58784
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2586-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100294
  • 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,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c v - Product Code MZP
  • Causa
    The cobas ampliprep/cobas taqman hcv test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.
  • Acción
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2011 and faxback form to their customers UPS ground. The letter described the product, problem and actions to be taken. The customers were instructed to review prior test results if there have been indications of discrepancies between test results generated with COBAS AmpliPrep/COBAS TaqMan HCV Test as compared to other relevant clinical and laboratory findings; complete and return the attached Product Advisory Notice: Affiliate Feedback Fax-Form via fax to: 1-866-792-5445, and file this letter for future reference, in particular for use with their 2010 CAP Survey Results to explain any under-quantitation of sample HVL 2-01. Please contact Roche Molecular Diagnostics Technical Support at 1-800-526-1247 if you have any questions about the information contained in this letter.
Retiro De Equipo (Recall) de COBAS AmpliPrep / COBAS TaqMan HCV Test, CEIVD
  • Tipo de evento
    Recall
  • ID del evento
    58784
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2587-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100296
  • 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,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c v - Product Code MZP
  • Causa
    The cobas ampliprep/cobas taqman hcv test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.
  • Acción
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2011 and faxback form to their customers UPS ground. The letter described the product, problem and actions to be taken. The customers were instructed to review prior test results if there have been indications of discrepancies between test results generated with COBAS AmpliPrep/COBAS TaqMan HCV Test as compared to other relevant clinical and laboratory findings; complete and return the attached Product Advisory Notice: Affiliate Feedback Fax-Form via fax to: 1-866-792-5445, and file this letter for future reference, in particular for use with their 2010 CAP Survey Results to explain any under-quantitation of sample HVL 2-01. Please contact Roche Molecular Diagnostics Technical Support at 1-800-526-1247 if you have any questions about the information contained in this letter.
Retiro De Equipo (Recall) de BACTEC" FX System Software
  • Tipo de evento
    Recall
  • ID del evento
    58873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2626-2011
  • Fecha de inicio del evento
    2010-08-10
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100453
  • 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, blood culturing - Product Code MDB
  • Causa
    In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
  • Acción
    BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken. The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit. Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.
Retiro De Equipo (Recall) de Mettler Traction Decompression System, Model: ME 4000
  • Tipo de evento
    Recall
  • ID del evento
    58787
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2580-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100298
  • 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
    Equipment, traction, powered - Product Code ITH
  • Causa
    The recall was initiated because mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding electronics traction device - mtd4000. the firm are initiating the recall because component failure might result in patient injury. use of the device should cease immediately.
  • Acción
    Mettler Electronics sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 14, 2011 to all affected consignees. The letter identified the product, the problem and the actions to be taken. Customers were instructed to immediately cease use of the recalled device, examine their inventory and quarantine product subject to recall. In addition, consignees were told if they have further distributed the affected product to please identify their customers and notify them at once of this product recall. The letter asks that that each includes a "Recall Return Response Form" that consignees are required to complete and return. If you have any questions please contact Mettler Electronics Corp 714-533-2221 x331, Monday through Friday, between the hours of 8:30 A.M. and 4:00 P.M. Pacific Time.
Retiro De Equipo (Recall) de Maquet Magnus Carbonfibre table top
  • Tipo de evento
    Recall
  • ID del evento
    58789
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2238-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2011-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100300
  • 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
    Table, radiologic - Product Code KXJ
  • Causa
    Maquet gmbh's quality monitoring detected that incorrect cover sheets were installed with some magnus carbon fibre table tops.
  • Acción
    Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected "MAGNUS 1180.16F0 carbon-fibre table tops." The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred. If you have additional questions, please contact yur local MAQUET Customer Service at 1-888-627-8383
Retiro De Equipo (Recall) de Servoi Ventilator Systems
  • Tipo de evento
    Recall
  • ID del evento
    58793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2628-2011
  • Fecha de inicio del evento
    2011-04-20
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100305
  • 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
    Through customer complaints, maquet has been informed that servo-i ventilators have stopped to ventilate and have generated three different technical error codes.
  • Acción
    Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.
Retiro De Equipo (Recall) de Servos Ventilator Systems
  • Tipo de evento
    Recall
  • ID del evento
    58793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2629-2011
  • Fecha de inicio del evento
    2011-04-20
  • Fecha de publicación del evento
    2011-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100306
  • 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
    Through customer complaints, maquet has been informed that servo-i ventilators have stopped to ventilate and have generated three different technical error codes.
  • Acción
    Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.
Retiro De Equipo (Recall) de Discovery Elbow System with Humeral Condyle
  • Tipo de evento
    Recall
  • ID del evento
    58864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2660-2011
  • Fecha de inicio del evento
    2011-04-29
  • Fecha de publicación del evento
    2011-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100452
  • 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
    Prothesis, elbow, constrained, cemented - Product Code JDC
  • Causa
    The firm initiated this recall after becoming aware that a discovery condyle kit with hexalobula contained two male condyles instead of a male and female condyle.
  • Acción
    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated May 25, 2011 to all affected customers. The notice describes the product, problem, and actions to be taken by the customers. The notice instructed customers to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Additionally, customers were instructed to ship the package priority mail with a copy of the response form. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday 8 AM to 5 PM.
Retiro De Equipo (Recall) de Churchill Medical Systems
  • Tipo de evento
    Recall
  • ID del evento
    58794
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2388-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-06-11
  • 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=100307
  • 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
    Dressing Change Kit - Product Code LKB
  • Causa
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Acción
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Retiro De Equipo (Recall) de Churchill Medical Systems
  • Tipo de evento
    Recall
  • ID del evento
    58794
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2389-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-06-11
  • 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=100308
  • 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
    Central Line Dressing Kit - Product Code LKB
  • Causa
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Acción
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Retiro De Equipo (Recall) de Churchill Medical Systems
  • Tipo de evento
    Recall
  • ID del evento
    58794
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2390-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-06-11
  • 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=100309
  • 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
    PICC insertion Tray - Product Code LKB
  • Causa
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Acción
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Retiro De Equipo (Recall) de Churchill Medical Systems
  • Tipo de evento
    Recall
  • ID del evento
    58794
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2391-2011
  • Fecha de inicio del evento
    2011-04-19
  • Fecha de publicación del evento
    2011-06-11
  • 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=100310
  • 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
    Dressing Change Kit - Product Code LKB
  • Causa
    Skin-prep wipes purchased by churchill (a vygon company) for inclusion into dressing kits and picc insertion kits were recalled by the manufacturer due to potential bacterial contamination.
  • Acción
    A recall letter printed on Vygon letterhead dated April 20, 2011 and specific to each customer was sent via overnight courier mail. The letter described the affected product, issue and actions to take. Customers were instructed to check their inventory for the recalled products, cease use and distribution, and quarantine all affected product. Each customer received a custom copy of the letter with the specific product codes and lots that were shipped to them described in the Recall Acknowledgement and Inventory Return Form. Distributors were provided with instructions on how to handle product that was further distributed by them. The firm issued an updated Recall Notice dated May 31, 2011 to two consignees effected by the expanded recall. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Retiro De Equipo (Recall) de Access Immunoassay Systems
  • Tipo de evento
    Recall
  • ID del evento
    58719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3126-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2012-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100311
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The recall was initiated because certain access immunoassays can produce inaccurate results when performed within the published unicel dxi immunoassay systems* room temperature operating specification of 18 degrees c to 32 degrees c (64.4 degrees f to 89.6 degrees f). an increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i.
  • Acción
    Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.
Retiro De Equipo (Recall) de UniCel DxI 800 Access Immunoassay Systems
  • Tipo de evento
    Recall
  • ID del evento
    58719
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3127-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2012-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100312
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The recall was initiated because certain access immunoassays can produce inaccurate results when performed within the published unicel dxi immunoassay systems* room temperature operating specification of 18 degrees c to 32 degrees c (64.4 degrees f to 89.6 degrees f). an increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i.
  • Acción
    Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.
Retiro De Equipo (Recall) de CDI 500
  • Tipo de evento
    Recall
  • ID del evento
    58532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2680-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100322
  • 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 parameter monitoring system - Product Code DRY
  • Causa
    Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient. the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
  • Acción
    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
Retiro De Equipo (Recall) de CDI 500
  • Tipo de evento
    Recall
  • ID del evento
    58532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2681-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100323
  • 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 parameter monitoring system - Product Code DRY
  • Causa
    Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient. the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
  • Acción
    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
Retiro De Equipo (Recall) de DeRoyal Incision and Drainage Tray
  • Tipo de evento
    Recall
  • ID del evento
    59272
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2891-2011
  • Fecha de inicio del evento
    2011-04-28
  • Fecha de publicación del evento
    2011-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102088
  • 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
    Tray Surgical - Product Code LRP
  • Causa
    Custom surgical kits contain recalled triad pvp prep pads.
  • Acción
    DeRoyal sent a Customer letter dated July 6, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to reference the attached spreadsheet to identify your accounts kits/trays and the corresponding lot numbers affected by this recall. Please complete and return the Acknowledgement Form by fax ( 865-362-3716) confirming you have been notified of this action. For further questions, please call ( 865) 362-2334.
Retiro De Equipo (Recall) de CDI 500
  • Tipo de evento
    Recall
  • ID del evento
    58532
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2682-2011
  • Fecha de inicio del evento
    2011-04-21
  • Fecha de publicación del evento
    2011-06-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100324
  • 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 parameter monitoring system - Product Code DRY
  • Causa
    Inaccurate readings may result after methylene blue, an intravascular dye, is administered to the patient. the presence of methylene blue may interfere with the readings from the shunt sensor for the cdi 500 system in a way that would cause inaccurate ph values. because the ph value is used to calculate other values, these parameters could also be affected by the presence of methylene blue: k.
  • Acción
    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.
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