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  • Dispositivo 514
  • Fabricante 58
  • Evento 124969
  • Implante 1
Retiro De Equipo (Recall) de Device Recall CareFusion Wet PVPI Small Procedure Preoperative Skin...
  • Tipo de evento
    Recall
  • ID del evento
    61103
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1207-2012
  • Fecha de inicio del evento
    2012-02-07
  • Fecha de publicación del evento
    2012-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107303
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Causa
    The povidone-iodine (pvp-i) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (eo) sterilant and/or by-products within the pvp-i solution, which may represent a patient safety hazard.
  • Acción
    CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.
Retiro De Equipo (Recall) de Device Recall Micromax Anchors
  • Tipo de evento
    Recall
  • ID del evento
    61104
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1231-2012
  • Fecha de inicio del evento
    2012-01-25
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107305
  • 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
    Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). this meant that the indications, contraindications, possible adverse effects, and some warnings are not present with the packaged device.
  • Acción
    Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST)
Retiro De Equipo (Recall) de Device Recall LATITUDE Patient Management System Communicator
  • Tipo de evento
    Recall
  • ID del evento
    61107
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1135-2012
  • Fecha de inicio del evento
    2012-01-19
  • Fecha de publicación del evento
    2012-03-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107311
  • 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
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Causa
    One (1) model 6476 latitude communicator is unable to interrogate the patient's pulse generator. boston scientific has determined that this is due to a patient receiving an incorrect communicator. therefore the communicator did not find and was unable to interrogate the assigned patients pg. additionally when the patient attempted to set-up this incorrect communicator, the system reflected.
  • Acción
    On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.
Retiro De Equipo (Recall) de Device Recall CareFusion Wet PVPI Preoperative Skin Prep Tray
  • Tipo de evento
    Recall
  • ID del evento
    61103
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1208-2012
  • Fecha de inicio del evento
    2012-02-07
  • Fecha de publicación del evento
    2012-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107312
  • 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
    Skin prep tray (kit) - Product Code OJU
  • Causa
    The povidone-iodine (pvp-i) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (eo) sterilant and/or by-products within the pvp-i solution, which may represent a patient safety hazard.
  • Acción
    CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.
Retiro De Equipo (Recall) de Device Recall Salmonella typhi IgG/IgM Duo Test
  • Tipo de evento
    Recall
  • ID del evento
    67665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1354-2014
  • Fecha de inicio del evento
    2014-03-04
  • Fecha de publicación del evento
    2014-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125979
  • 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
  • Causa
    Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
  • Acción
    Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
Retiro De Equipo (Recall) de Device Recall CareFusion Wet PVPI Vaginal Preoperative Skin Prep Tray
  • Tipo de evento
    Recall
  • ID del evento
    61103
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1209-2012
  • Fecha de inicio del evento
    2012-02-07
  • Fecha de publicación del evento
    2012-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107313
  • 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
    Applicator, vaginal - Product Code HGD
  • Causa
    The povidone-iodine (pvp-i) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (eo) sterilant and/or by-products within the pvp-i solution, which may represent a patient safety hazard.
  • Acción
    CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.
Retiro De Equipo (Recall) de Device Recall TruFlight Select PET/CT Scanning System
  • Tipo de evento
    Recall
  • ID del evento
    61110
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1056-2012
  • Fecha de inicio del evento
    2011-12-13
  • Fecha de publicación del evento
    2012-02-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107316
  • 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, tomography, computed, emission - Product Code KPS
  • Causa
    A number of non-conformances have been noted in the truflight select pet/ct system. a number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units.
  • Acción
    Philips sent an 'URGENT - Medical Device Correction TruFlight Select PET/CT Serial Numbers: 17002, 17003 letters. The letter was dated December 13, 2011. The letter describes the affected product, the nature of the problem along with the circumstances under which this problem can occur; the hazard involved and actions to be taken by the customer/user. In this case, the customers (operator/users) are provided with separate recommended actions. The letter goes on to notify the customers that a Philips representative will be visiting each customer site and installing a software update (3.5.3) in order to address several of the non-conformance issues through a Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center at (1-800-722-9377, Customers in all other countries are advised to dial their local Philips Healthcare office.
Retiro De Equipo (Recall) de Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide
  • Tipo de evento
    Recall
  • ID del evento
    61041
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1144-2012
  • Fecha de inicio del evento
    2011-11-17
  • Fecha de publicación del evento
    2012-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107319
  • 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
    Ankle arthroplasty implantation system - Product Code OYK
  • Causa
    During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compression is applied between talus and tibia. (step 3 of the product description) or when 2) the surgeon screws the compression guide into the plate which most likely was attributed to improper surgical techniques used durin.
  • Acción
    Integra sent a "Field Safety Notice" letter dated November 17, 2011 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review the Surgical Techinique Manual and follow the recommended guiidelines to avoid breakage. ensure that this information is distributed to their surgical teams, and fill out the enclosed "Field Safety Notice Acknowledgement and Return Form" and return to bonnie.kuzbyt@integralife.com or fax to 1-609-750-7999. For questions call 609-936-6932 or email at sean.luland@integralife.com.
Retiro De Equipo (Recall) de Device Recall TSX301A: AQUILION ONE; System, XRay, Tomography, Comp...
  • Tipo de evento
    Recall
  • ID del evento
    61111
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1034-2012
  • Fecha de inicio del evento
    2012-01-03
  • Fecha de publicación del evento
    2012-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107320
  • 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, X-ray, Tomography, computed - Product Code JAK
  • Causa
    The recall was initiated because toshiba has confirmed that their is a potential software issue for the tsx-301a aquilon one and the tsx-301b aquilon one.
  • Acción
    Toshiba sent an Urgent Medical Device Correction letter to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax the attached form to (877) 349-3054. The form can also be sent via email to raffairs@tams.com. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Retiro De Equipo (Recall) de Device Recall Syngo RT
  • Tipo de evento
    Recall
  • ID del evento
    61121
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1092-2012
  • Fecha de inicio del evento
    2012-01-22
  • Fecha de publicación del evento
    2012-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107337
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Software upgrade to installed base to the latest release of the rt therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
  • Acción
    Siemens customers with active devices will receive the software update through the distribution of the "Update Instructions" with a release date of January 22, 2012. The software update will be delivered and installed by a qualified Field Service Engineer utilizing a SW kit and instruction distributed by the Update instruction. Consignee notification of the Update Instructions will be delivered by Customer Service or by certified mail.
Retiro De Equipo (Recall) de Device Recall TSX301B: AQUILION ONE; System, XRay, Tomography, Comp...
  • Tipo de evento
    Recall
  • ID del evento
    61111
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1035-2012
  • Fecha de inicio del evento
    2012-01-03
  • Fecha de publicación del evento
    2012-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107321
  • 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, X-ray, Tomography, computed - Product Code JAK
  • Causa
    The recall was initiated because toshiba has confirmed that their is a potential software issue for the tsx-301a aquilon one and the tsx-301b aquilon one.
  • Acción
    Toshiba sent an Urgent Medical Device Correction letter to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax the attached form to (877) 349-3054. The form can also be sent via email to raffairs@tams.com. Customers with any questions regarding this letter were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Retiro De Equipo (Recall) de Device Recall Rotating Cutter
  • Tipo de evento
    Recall
  • ID del evento
    61117
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1037-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107325
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    surgical instrument - Product Code max
  • Causa
    The 8mm and 10mm rotating cutters may fracture during use, specifically during disc space preparation. if an 8mm or 10mm rotating cutter does fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
  • Acción
    Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.
Retiro De Equipo (Recall) de Device Recall SoundBite Microphone Tube
  • Tipo de evento
    Recall
  • ID del evento
    61114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1179-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107326
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Causa
    Sonitas received reports of stress cracking on the soundbite microphone tube.
  • Acción
    Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Retiro De Equipo (Recall) de Device Recall SoundBite Microphone Tube
  • Tipo de evento
    Recall
  • ID del evento
    61114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1180-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107327
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Causa
    Sonitas received reports of stress cracking on the soundbite microphone tube.
  • Acción
    Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Retiro De Equipo (Recall) de Device Recall SoundBite Microphone Tube
  • Tipo de evento
    Recall
  • ID del evento
    61114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1181-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107328
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Causa
    Sonitas received reports of stress cracking on the soundbite microphone tube.
  • Acción
    Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Retiro De Equipo (Recall) de Device Recall SoundBite Microphone Tube
  • Tipo de evento
    Recall
  • ID del evento
    61114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1182-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107329
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Causa
    Sonitas received reports of stress cracking on the soundbite microphone tube.
  • Acción
    Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Retiro De Equipo (Recall) de Device Recall SoundBite Microphone Tube
  • Tipo de evento
    Recall
  • ID del evento
    61114
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1183-2012
  • Fecha de inicio del evento
    2012-02-02
  • Fecha de publicación del evento
    2012-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107330
  • 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
    Hearing aid, bone conduction - Product Code LXB
  • Causa
    Sonitas received reports of stress cracking on the soundbite microphone tube.
  • Acción
    Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Retiro De Equipo (Recall) de Device Recall SYNCHRON CX(r) systems, ImmunoProtein Calibrator Set
  • Tipo de evento
    Recall
  • ID del evento
    61122
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1229-2012
  • Fecha de inicio del evento
    2009-08-26
  • Fecha de publicación del evento
    2012-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107339
  • 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
    Calibrator, multi-analyte mixture - Product Code JIT
  • Causa
    A recall was initiated because beckman has confirmed that the standardization of the immuno protein calibrator set has been re-established to ifcc reference preparation for plasma proteins, bcr-470 beginning with lot number m901330.
  • Acción
    Beckman Coulter sent an Urgent Field Safety Notice letter dated August 24, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers with questions regarding the product correction action were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-993-8916.
Retiro De Equipo (Recall) de Device Recall BENEPHIT CV Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    61123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1112-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107340
  • 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
    Catheter, continuous flush - Product Code KRA
  • Causa
    The benephit cv infusion system contains a sheath y connector that has the potential to develop cracks.
  • Acción
    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com
Retiro De Equipo (Recall) de Device Recall BENEPHIT CV Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    61123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1113-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107341
  • 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
    Catheter, continuous flush - Product Code KRA
  • Causa
    The benephit cv infusion system contains a sheath y connector that has the potential to develop cracks.
  • Acción
    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com
Retiro De Equipo (Recall) de Device Recall BENEPHIT CV Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    61123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1114-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107342
  • 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
    Catheter, continuous flush - Product Code KRA
  • Causa
    The benephit cv infusion system contains a sheath y connector that has the potential to develop cracks.
  • Acción
    Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to customerservice@angiodynamics.com
Retiro De Equipo (Recall) de Device Recall Oridion
  • Tipo de evento
    Recall
  • ID del evento
    61143
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1348-2012
  • Fecha de inicio del evento
    2011-12-01
  • Fecha de publicación del evento
    2012-03-30
  • 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=107387
  • 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, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Surestream co2 sampling lines-connector may cause breakage of the microswitch inside the co2 inlet.
  • Acción
    Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at technicalsupport@oridion.com
Retiro De Equipo (Recall) de Device Recall Morpheus Smart PICC
  • Tipo de evento
    Recall
  • ID del evento
    61124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1068-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107343
  • 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
    Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
  • Causa
    The morpheus smart picc label states the kit contains a nitinol guidewire; however the kit contains a platinum guidewire.
  • Acción
    AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
Retiro De Equipo (Recall) de Device Recall Morpheus Smart PICC
  • Tipo de evento
    Recall
  • ID del evento
    61124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1069-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-02-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107344
  • 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
    Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
  • Causa
    The morpheus smart picc label states the kit contains a nitinol guidewire; however the kit contains a platinum guidewire.
  • Acción
    AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
Retiro De Equipo (Recall) de Device Recall Titanium Surfix Alpha Screws
  • Tipo de evento
    Recall
  • ID del evento
    61125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1147-2012
  • Fecha de inicio del evento
    2011-12-21
  • Fecha de publicación del evento
    2012-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107345
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Manufacturing error. the part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.
  • Acción
    Integra contacted the Sales Representatives and All USERS on December 21, 2011, with a 'SUBJECT: MEDICAL DEVICE RECALL' letter. The letter was sent via FedEx and/or E-mail. The letter describes the product, problem, and the actions to be taken by the customers and the firm. The customers are instructed to immediately examine their inventories for the presence of the recalled product, and complete and return the attached, MEDICAL DEVICE RECALL ACKNOWLEDGMENT AND RETURN FORM via E-mail or FAX #1-609-0750-7999. Any questions concerning the recall document are to be addressed to the customers' regional managers or to the E-mail address and/or telephone number provided on the recall notification.
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