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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Merge PACS
  • Tipo de evento
    Recall
  • ID del evento
    77249
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2591-2017
  • Fecha de inicio del evento
    2017-05-08
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155552
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. this may cause a misdiagnosis.
  • Acción
    Merge sent an Urgent Medical Device Recall letter dated May 5, 2017, to all affected customers. Customers were instructed to be aware of the following workaround: Do not have the simple close study red x icon available in the reading physicians toolbars. This will force them to set status on close which also presents the warning Not all images have been reviewed, do you want to set status anyway and close study or continue reviewing unviewed images? YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED By replying to this notification, you will be taking the necessary steps to ensure that the issue listed in this document will be resolved. Please reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-6369.
Retiro De Equipo (Recall) de Device Recall DRXRevolution Mobile XRay System
  • Tipo de evento
    Recall
  • ID del evento
    77250
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2651-2017
  • Fecha de inicio del evento
    2017-05-25
  • Fecha de publicación del evento
    2017-06-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155553
  • 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, mobile - Product Code IZL
  • Causa
    Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. this could result in separation of the tube and yoke assembly.
  • Acción
    Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.
Retiro De Equipo (Recall) de Device Recall Vitality Spinal Fixation System
  • Tipo de evento
    Recall
  • ID del evento
    77251
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2318-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155554
  • 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
    Accessories, fixation, spinal intervertebral body - Product Code LYQ
  • Causa
    Zimmer biomet is conducting a medical device recall for vitality t27 final drivers and vitality torque limiting handle  90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
  • Acción
    Consignees will be notified on 5/15/17 via certified mail to return products.
Retiro De Equipo (Recall) de Device Recall LATARJET EXPERIENCECombo Screw Driver
  • Tipo de evento
    Recall
  • ID del evento
    77252
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2615-2017
  • Fecha de inicio del evento
    2017-05-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155555
  • 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
    Combo screw driver (product code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw.
  • Acción
    DePuy Mitek issued recall letter dated May 12, 2017 advising of the problem and requesting return of the product. A Response Form is to be completed and returned. Questions: contact your DePuy Synthes Mitek Sales Consultant or Carolyn Somerville, DePuy Mitek, Inc. (via telephone: 508.828.3647 Fax: 508.828.3762 or via email: DPYUS-MitekFieldActions@its.jnj.com).
Retiro De Equipo (Recall) de Device Recall Oxygen Mask, Elongated (Under the Chin) Pediatric
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2240-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155618
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall Multiphor" II Electrophoresis System
  • Tipo de evento
    Recall
  • ID del evento
    77267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2685-2017
  • Fecha de inicio del evento
    2017-05-15
  • Fecha de publicación del evento
    2017-05-22
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155585
  • 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
    Apparatus, electrophoresis, for clinical use - Product Code JJN
  • Causa
    Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
  • Acción
    Perkin Elmer issued URGENT: Field Correction letter on 5/15/17 and accompanied with the GE HealthCare Important Product Information letter The notifications will be delivered to the end customer by email facilitated through PerkinElmer Technical Support group located in Akron Ohio. Technical Support will ensure the customers receive the both letters and understand the recommended actions. Accounts requested to complete the enclosed Response Form. Questions regarding the actions to be taken, as outlined in the GE HealthCare letter, should be directed via email to orderFI@ge.com or via phone (in the US) 011 44 800 515313, (in the UK) 0800 515 313, and (rest of world) +44-800 515 313.
Retiro De Equipo (Recall) de Device Recall Merge OrthoPACS
  • Tipo de evento
    Recall
  • ID del evento
    77271
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2601-2017
  • Fecha de inicio del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155590
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Studies that have qc, pde, or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
  • Acción
    Merge Healtcare sent an Urgent Medical Device Recall letter dated May 19, 2017, via email on May 24, 2017. The letter notifies the customer of the issue, informs them to be aware of the workaround, and that a fix is available for the issue in Merge OrthoPACS 6.6.3.2 (or later). The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required 15 calendar days after receipt of the recall letter using the enclosed form. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The recalling firm will contact all unresponsive customers with a second customer letter, followed by a third customer letter. They may additionally contact customers that are unresponsive via telephone. For further questions, please call ( 877) 741-5369.
Retiro De Equipo (Recall) de Device Recall Arterial Needles
  • Tipo de evento
    Recall
  • ID del evento
    77273
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2252-2017
  • Fecha de inicio del evento
    2017-05-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155591
  • 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
    Saw, manual and accessories - Product Code GDR
  • Causa
    Argon medical has received a complaint from one of their distributors of a potential packaging defect. the product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch.
  • Acción
    Argon Medical Devices, Inc. is sending an Urgent Medical Device Recall letter by registered mail to the affected customer/hospital/distributor. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form.
Retiro De Equipo (Recall) de Device Recall Acumedia Nutrient Gelatin
  • Tipo de evento
    Recall
  • ID del evento
    77275
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2213-2017
  • Fecha de inicio del evento
    2016-03-23
  • Fecha de publicación del evento
    2017-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155595
  • 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
    Culture media, non-selective and non-differential - Product Code JSG
  • Causa
    Incorrect expiration date was listed on the label. correct expiration date was november 30, 2016. product was labeled with expiration date of april 30, 2018.
  • Acción
    On 3/23/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.
Retiro De Equipo (Recall) de Device Recall Kii Shielded Bladed Access System and Kii Low Profile...
  • Tipo de evento
    Recall
  • ID del evento
    77277
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2533-2017
  • Fecha de inicio del evento
    2017-05-04
  • Fecha de publicación del evento
    2017-06-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155597
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Due to possibility of insufficient sterilization.
  • Acción
    An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60738625@appliedmedical.com or faxing to 949-713-8847. The recall letter instructs the customers that for product return questions to contact Karen Mitchell, Associate Manager Sales Operations, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at contursi@appliedmedical.com. On 8/21/17 an Urgent Medical Device recall letter was sent to their customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of the Kii trocar model, CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. During shipment, the trocar packaging has the potential to become punctured with small holes, which would compromise the sterile barrier.
Retiro De Equipo (Recall) de Device Recall Millipore
  • Tipo de evento
    Recall
  • ID del evento
    28223
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0573-04
  • Fecha de inicio del evento
    2004-01-26
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31404
  • 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
    Filter, Infusion Line - Product Code FPB
  • Causa
    Lack of assurance of sterility.
  • Acción
    Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
Retiro De Equipo (Recall) de Device Recall Oxygen Masks, Elongated
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2228-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155601
  • 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
    Mask, oxygen - Product Code BYG
  • Causa
    Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. the failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. while the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall Rebreathing Mask
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2229-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155602
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall NonRebreathing Mask
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2230-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155603
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall Oxygen Mask
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2231-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155604
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall Oxygen Masks
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2232-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155605
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall NonRebreather Oxygen Mask
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2233-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155606
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Retiro De Equipo (Recall) de Device Recall Acumedia Palcam Supplement
  • Tipo de evento
    Recall
  • ID del evento
    77283
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2584-2017
  • Fecha de inicio del evento
    2015-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155607
  • 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
    Culture media, selective and differential - Product Code JSI
  • Causa
    Contamination of product with possible bacillus spp.
  • Acción
    On 11/30/2015 and 1/21/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and offers replacement product.
Retiro De Equipo (Recall) de Device Recall NonRebreathing Mask
  • Tipo de evento
    Recall
  • ID del evento
    77282
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2241-2017
  • Fecha de inicio del evento
    2017-05-10
  • Fecha de publicación del evento
    2017-05-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155619
  • 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
    Mask, oxygen - Product Code BYG
  • Acción
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
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