Retiro De Equipo (Recall) de Device Recall Gaymar MediTherm

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Stryker Medical Division of Stryker Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66861
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0933-2014
  • Fecha de inicio del evento
    2013-12-27
  • Fecha de publicación del evento
    2014-02-05
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2014-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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, thermal regulating - Product Code DWJ
  • Causa
    Stryker medical has identified that on some units of the mta7900, there is a lack of a water temperature display while the unit is in auto mode. while in auto mode, only the patient temperature is displayed along with the set point. the water display will be blank during auto mode. if the user wants to see the water temperature displayed and switches out of auto mode to manual mode, then back to.
  • Acción
    On Dec. 27, 2013, Stryker Medical notified their consignees, identifying the product, reason for the recall and associated risks. Consignees were asked . Locate the units listed attach enclosed warning tags to the units listed. For units that do not have the water temperature displayed, advise staff not to switch to manual mode in order to display the water temperature. Stryker will make arrangements to update the software so that the water temperature will be displayed in both Auto and Manual modes. Fax (269-488-8691) or e-mail (ProductFieldAction@stryker.com ) the enclosed acknowledgment to confirm receipt of this notification. Please forward a copy of this letter to the new users and advise us of their new location and let Stryker know if any units have been discontinued. Questions or concerns, should be addressed to Stryker Customer Service at (1-800-327-0770). Monday-Friday 8 a.m-5 p.m. (ET).

Device

  • Modelo / Serial
    Domestic Serial Numbers  MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 MTA7900I90027 MTA7900E90031 MTA7900I90031 MTA7900I90041 MTA7900H90004 MTA7900B80004 MTA7900A80028 MTA7900E80054 MTA7900E01042 MTA7900D80001 MTA7900C01012 MTA7900J90018 MTA7900A01028 MTA7900E80046 MTA7900J70023 MTA7900J70024 MTA7900J70025 MTA7900J70026 MTA7900J70027 MTA7900J70031 MTA7900J70032 MTA7900E80011 MTA7900E80035 MTA7900H80014 MTA7900H80018 MTA7900H80019 MTA7900A90017 MTA7900K80010 MTA7900K80011 MTA7900K80012 MTA7900K80013 MTA7900L80001 MTA7900L80004 MTA7900L80013 MTA7900E80059 MTA7900A01014 MTA7900H90019 MTA7900H90020 MTA7900H90021 MTA7900H90022 MTA7900H90023 MTA7900D80055 MTA7900J90035 MTA7900J70028 MTA7900H80023 MTA7900A80032 MTA7900J70029 MTA7900I80029 MTA7900C80001 MTA7900C80002 MTA7900C80003 MTA7900J90027 MTA7900D80006 MTA7900E80029 MTA7900E80040 MTA7900E80065 MTA7900D01022 MTA7900E01022 MTA7900B01036 MTA7900F01010 MTA7900D90030 MTA7900K90003 MTA7900C01009 MTA7900C01025 MTA7900J60008 MTA7900A01032 MTA7900K90004 MTA7900E01029 MTA7900E90017 MTA7900J70022 MTA7900K90019 MTA7900B01040 MTA7900B01043 MTA7900B01024 MTA7900A90001 MTA7900A90005 MTA7900A90008 MTA7900E80022 MTA7900G80009 MTA7900G80011 MTA7900H80002 MTA7900H80003 MTA7900H80006 MTA7900H80007 MTA7900H80008 MTA7900H80010 MTA7900H80011 MTA7900H80012 MTA7900H80013 MTA7900L70008 MTA7900L70009 MTA7900G60063 MTA7900K40071 MTA7900B01019 MTA7900F01014 MTA7900C90010 MTA7900J80039 MTA7900K90053 MTA7900K90054 MTA7900A90012 MTA7900A90016 MTA7900A90020 MTA7900J90036 MTA7900K80005 MTA7900H80026 MTA7900L90017 MTA7900I90003 MTA7900I90008 MTA7900F01051 MTA7900I90043 MTA7900I90044 MTA7900I90046 MTA7900I90048 MTA7900G90012 MTA7900K90018 MTA7900J80051 MTA7900J80054 MTA7900A90030 MTA7900C90001 MTA7900F90018 MTA7900F90022 MTA7900L50006 MTA7900E01010 MTA7900H90009 MTA7900H90010 MTA7900H90014 MTA7900H90015 MTA7900H90016 MTA7900D90006 MTA7900D90009 MTA7900D90012 MTA7900D90013 MTA7900D90014 MTA7900D90015 MTA7900B90033 MTA7900I80025 MTA7900B01041 MTA7900C01002 MTA7900L90001 MTA7900B90017 MTA7900C01013 MTA7900C01018 MTA7900J80028 MTA7900A01045 MTA7900F90035 MTA7900E80058 MTA7900E80070 MTA7900K90001 MTA7900D80011 MTA7900I90022 MTA7900I90028 MTA7900A90034 MTA7900A90035 MTA7900G80007 MTA7900K90015 MTA7900J90011 MTA7900E80002 MTA7900E80021 MTA7900E80023 MTA7900E80025 MTA7900E80037 MTA7900E80044 MTA7900E80050 MTA7900E80055 MTA7900E80057 MTA7900E80060 MTA7900E80061 MTA7900E80062 MTA7900E80066 MTA7900E80067 MTA7900E80069 MTA7900E80071 MTA7900E80073 MTA7900E80074 MTA7900E80076 MTA7900E80078 MTA7900E80079 MTA7900H80039 MTA7900J80022 MTA7900A01005 MTA7900C01003 MTA7900C01011 MTA7900J90023 MTA7900D80027 MTA7900B01022 MTA7900H80032 MTA7900A01018 MTA7900A01027 MTA7900A01040 MTA7900B01016 MTA7900B01017 MTA7900B01021 MTA7900B01025 MTA7900L90011 MTA7900L90014 MTA7900D01024 MTA7900E01025 MTA7900I90040 MTA7900F01006 MTA7900G90006 MTA7900H80017 MTA7900B90014 MTA7900C90021 MTA7900I90032 MTA7900C90003 MTA7900A01001 MTA7900A01003 MTA7900A01046 MTA7900A70012 MTA7900A70013 MTA7900A70016 MTA7900A70019 MTA7900J70019 MTA7900J80027 MTA7900J80030 MTA7900E80017 MTA7900E80030 MTA7900E80034 MTA7900L90004 MTA7900A01034 MTA7900J80021 MTA7900J80041 MTA7900B01010 MTA7900F01011 MTA7900B80001 MTA7900A01030 MTA7900J90034 MTA7900D80031 MTA7900E90021 MTA7900D90026 MTA7900D90027 MTA7900L70007 MTA7900K90031 MTA7900F01005 MTA7900F90012 MTA7900F90014 MTA7900L90018 MTA7900E90020 MTA7900J90016 MTA7900F01056 MTA7900D80043 MTA7900J90005 MTA7900L90007 MTA7900E90004 MTA7900B01031 MTA7900C01020 MTA7900A90007 MTA7900A80041 MTA7900A80042 MTA7900A80043 MTA7900A80046 MTA7900F01039 MTA7900C90007 MTA7900J90026 MTA7900H80055 MTA7900I80009 MTA7900I80010 MTA7900I80011 MTA7900I80012 MTA7900L90015 MTA7900I90020 MTA7900I90021 MTA7900E80026 MTA7900E90026 MTA7900F90002 MTA7900L80003 MTA7900L80010 MTA7900A80031 MTA7900A80017 MTA7900D80053 MTA7900J80023 MTA7900J80024 MTA7900F01029 MTA7900F90031 MTA7900F90032 MTA7900G90009 MTA7900G90010 MTA7900G90020 MTA7900H80029 MTA7900J80038 MTA7900B90032 MTA7900J90012 MTA7900A80019 MTA7900D90024 MTA7900J90024 MTA7900I80014 MTA7900I80015 MTA7900I80016 MTA7900C90017 MTA7900H90002 MTA7900J90028 MTA7900F90015 MTA7900L80002 MTA7900L80011 MTA7900B01035 MTA7900B01038 MTA7900B01039 MTA7900C01001 MTA7900E01014 MTA7900A80002 MTA7900A80025 MTA7900D01013 MTA7900E01038 MTA7900K90058 MTA7900K90060 MTA7900C01010 MTA7900C90008 MTA7900D80008 MTA7900D80009 MTA7900D80010 MTA7900G01010 MTA7900A80037 MTA7900D01023 MTA7900E01021 MTA7900J80018 MTA7900K80002 MTA7900H80027 MTA7900A01013 MTA7900A90003 MTA7900A90010 MTA7900J80026 MTA7900E80024 MTA7900E80039 MTA7900E80008 MTA7900H80046 MTA7900J80025 MTA7900K80003 MTA7900L80005 MTA7900F90021 MTA7900E80041 MTA7900E80051 MTA7900H80028 MTA7900H80042 MTA7900I80017 MTA7900I80018 MTA7900I80020 MTA7900I80022 MTA7900D80029 MTA7900E80048 MTA7900E80052 MTA7900E80053 MTA7900E80063 MTA7900E80064 MTA7900C90002 MTA7900C90016 MTA7900D80012 MTA7900D90003 MTA7900E90002 MTA7900E90005 MTA7900E90011 MTA7900J80029 MTA7900L80009 MTA7900B90031 MTA7900D90025 MTA7900F90001 MTA7900F90003 MTA7900F90007 MTA7900F90009 MTA7900F90011 MTA7900F90013 MTA7900E01035 MTA7900L80017 MTA7900J80036 MTA7900L80007 MTA7900L80012 MTA7900I90039 MTA7900I90042 MTA7900A80039 MTA7900L80014 MTA7900L80018 MTA7900E90023 MTA7900I90005 MTA7900I90007 MTA7900I90009 MTA7900D01008 MTA7900C01005 MTA7900C01006 MTA7900I90010 MTA7900C90018 MTA7900C90020 MTA7900A80038 MTA7900A90025 MTA7900A80012 MTA7900B01030 MTA7900K80008 MTA7900F01041 MTA7900F01055 MTA7900F01024 MTA7900E90025 MTA7900C90014 MTA7900E01005 MTA7900A01008 MTA7900B01014 MTA7900I80021 MTA7900I80024 MTA7900B01002 MTA7900B01026 MTA7900B01037 MTA7900F01022 MTA7900C90022 MTA7900D90005 MTA7900E80045 MTA7900E80075 MTA7900J80031 MTA7900J80032 MTA7900J80033 MTA7900J80035 MTA7900A70014 MTA7900A70015 MTA7900A90028 MTA7900A90031 MTA7900A90032 MTA7900D80028 MTA7900K90024 MTA7900K90027 MTA7900J90007 MTA7900J90020 MTA7900A01025 MTA7900A01026 MTA7900C01026 MTA7900E80031 MTA7900C01019 MTA7900A80036 MTA7900B01023 MTA7900F01037 MTA7900E01001 MTA7900B01001 MTA7900B01003 MTA7900B01004 MTA7900B01005 MTA7900B01007 MTA7900K90002 MTA7900A01015 MTA7900D80002 MTA7900F90034 MTA7900G80012 MTA7900G80014 MTA7900I90026 MTA7900I90029 MTA7900H80043 MTA7900A80015 MTA7900E80032 MTA7900E80036 MTA7900L90009 MTA7900B90009 MTA7900D90001 MTA7900D90004 MTA7900F01004 MTA7900J80043 MTA7900J80046 MTA7900K80001 MTA7900B90029 MTA7900C90013 MTA7900D90002 MTA7900D90007 MTA7900D90008 MTA7900D90010 MTA7900G01004 MTA7900G01005 MTA7900G01013 MTA7900G01014 MTA7900G01015 MTA7900D60059 MTA7900D60061 MTA7900E60002 MTA7900J70014 MTA7900J70020 MTA7900I90012 MTA7900B90027 MTA7900B90035 MTA7900B01027 MTA7900G90008 MTA7900I90036 MTA7900I90037 MTA7900J90022 MTA7900D90029 MTA7900A01042 MTA7900G80013 MTA7900K90057 MTA7900J90025 MTA7900B01033 MTA7900I90016 MTA7900I90017 MTA7900A80008 MTA7900A80009 MTA7900A80010 MTA7900A80014 MTA7900E80012 MTA7900E80015 MTA7900F90008 MTA7900E01037 MTA7900D80020 MTA7900D80021 MTA7900B01032 MTA7900A90004 MTA7900J80019 MTA7900G01011 MTA7900E01019 MTA7900A90027 MTA7900C90009 MTA7900C90011 MTA7900I90011 MTA7900I90014 MTA7900I80019 MTA7900J90017 MTA7900E90014 MTA7900E90016 MTA7900C01024 MTA7900D80013 MTA7900D80016 MTA7900D90011 MTA7900D80046 MTA7900E01004 MTA7900C01021 MTA7900E01033 MTA7900F01018 MTA7900F01023 MTA7900F01025 MTA7900F01028 MTA7900G90005 MTA7900F90006 MTA7900I90024 MTA7900I90025 MTA7900F01008 MTA7900F01031 MTA7900F01033 MTA7900F01040 MTA7900A80013 MTA7900A80024 MTA7900K90009 MTA7900K90013 MTA7900E01002 MTA7900E01015 MTA7900A01002 MTA7900L90023 MTA7900L90024 MTA7900L90025 MTA7900F01034 MTA7900B90018 MTA7900E90015 MTA7900J80017 MTA7900J80020 MTA7900J80040 MTA7900E80042 MTA7900K90014 MTA7900C80007 MTA7900A01016 MTA7900A01017 MTA7900H80016 MTA7900K80004 MTA7900D80007 MTA7900J70002 MTA7900G90015 MTA7900F01045 MTA7900A80020 MTA7900L90002 MTA7900L90005 MTA7900K90055 MTA7900L90012 MTA7900J90014 MTA7900J90015 MTA7900A80040 MTA7900J80045 MTA7900A80006 MTA7900A80044 MTA7900J90031 MTA7900J90032 MTA7900J90033 MTA7900D80048 MTA7900E01032 MTA7900F01027 MTA7900F01044 MTA7900F01054 MTA7900F01032 MTA7900F01050 MTA7900H80051 MTA7900E90022 MTA7900E90024 MTA7900E90029 MTA7900F90004 MTA7900B01042 MTA7900C01008 MTA7900G80002 MTA7900G80003 MTA7900G80005 MTA7900G80008 MTA7900H80038 MTA7900H90024 MTA7900I90018 MTA7900H80036 MTA7900J80034 MTA7900J80048 MTA7900B01013 MTA7900B01015 MTA7900K90030 MTA7900A80018 MTA7900F90029 MTA7900F90024 MTA7900K90039 MTA7900D80014 MTA7900D80015 MTA7900I80006 MTA7900L70002 MTA7900L70004 MTA7900F01012 MTA7900B90008 MTA7900B90028 MTA7900B90030 MTA7900A90029 MTA7900J90037 MTA7900L90010 MTA7900B90038 MTA7900H80044 MTA7900D01002 MTA7900D01004 MTA7900C90004 MTA7900D90016 MTA7900D90017 MTA7900C90012 MTA7900I90015 MTA7900I90019 MTA7900F90028 MTA7900J80042 MTA7900K90026 MTA7900K90029 MTA7900K90032 MTA7900K90033 MTA7900K90034 MTA7900K90036 MTA7900K90037 MTA7900K90040 MTA7900K90043 MTA7900K90006 MTA7900K90008 MTA7900E01017 MTA7900D80036 MTA7900A01035 MTA7900C01027 MTA7900C90015 MTA7900E90001 MTA7900E90006 MTA7900E90007 MTA7900E90008 MTA7900E90009 MTA7900E90012 MTA7900E90027 MTA7900A01006 MTA7900A01007 MTA7900A01009 MTA7900A01010 MTA7900A01011 MTA7900A01012 MTA7900C80004 MTA7900C80005 MTA7900F90023 MTA7900J90021 MTA7900E01027 MTA7900L70005 MTA7900C90006 MTA7900F90005 MTA7900D80003 MTA7900D80023 MTA7900D80024 MTA7900B90021 MTA7900E80038 MTA7900E90010 MTA7900A01033 MTA7900D01014 MTA7900D01019 MTA7900C01014 MTA7900A90002 MTA7900K90022 MTA7900D01001 MTA7900D01003 MTA7900E90013 MTA7900G90018 MTA7900G90019 MTA7900G90024 MTA7900H90018 MTA7900B90016 MTA7900H90005 MTA7900I90033 MTA7900I90034 MTA7900I90035 MTA7900A80048 MTA7900D80005 MTA7900D90020 MTA7900D90028 MTA7900E90003 MTA7900E80009 MTA7900H90001 MTA7900H90011 MTA7900J90029 MTA7900B01011 MTA7900B01020 MTA7900K90059 MTA7900B90007 MTA7900B90010 MTA7900E01040 MTA7900F01009 MTA7900G90013 MTA7900G90022 MTA7900A80047 MTA7900D80044 MTA7900D80045 MTA7900H80061 MTA7900I80002 MTA7900I90013 MTA7900H80056 MTA7900H80058 MTA7900H80059 MTA7900H80060 MTA7900E90030 MTA7900C80006 MTA7900C80008 MTA7900C80009 MTA7900A01041 MTA7900A01043 MTA7900B90037 MTA7900B90040 MTA7900B90042 MTA7900L90021 MTA7900L90022 MTA7900A90013 MTA7900J90013 MTA7900J90019 MTA7900E70005 MTA7900E70006 MTA7900F01046 MTA7900F01048 MTA7900G80004 MTA7900G80010 MTA7900G80006 MTA7900E01024 MTA7900H80037 MTA7900H80040 MTA7900D01005 MTA7900D01006 MTA7900D01007 MTA7900D01009 MTA7900D01010 MTA7900D01011 MTA7900H80022 MTA7900H80024 MTA7900H80031 MTA7900H80033 MTA7900H80035 MTA7900H80047 MTA7900H80048 MTA7900H80050 MTA7900H80052 MTA7900H80053 MTA7900H80054 MTA7900A80001 MTA7900L70010 MTA7900L70011 MTA7900L70012 MTA7900L70013 MTA7900L70015 MTA7900L70016 MTA7900L70017 MTA7900L70018 MTA7900L70019 MTA7900L70020 MTA7900L70021 MTA7900L70022 MTA7900L70023 MTA7900L70024 MTA7900A90011 MTA7900E80005 MTA7900E80072 MTA7900I80030 MTA7900I80031 MTA7900I80032 MTA7900I80033 MTA7900I80036 MTA7900I80037 MTA7900I80038 MTA7900I80039 MTA7900I80040 MTA7900I80041 MTA7900I80042 MTA7900I80043 MTA7900I80044 MTA7900I80045 MTA7900I80046 MTA7900I80047 MTA7900I80048 MTA7900I80049 MTA7900J80001 MTA7900J80002 MTA7900J80003 MTA7900J80004 MTA7900J80005 MTA7900J80006 MTA7900J80007 MTA7900J80008 MTA7900J80009 MTA7900J80010 MTA7900J80011 MTA7900J80012 MTA7900J80013 MTA7900D80050 MTA7900B80003 MTA7900D80032 MTA7900D80038 MTA7900D80039 MTA7900D80041 MTA7900D80042 MTA7900B01029 MTA7900B01034 MTA7900D90018 MTA7900H90017 MTA7900H90025 MTA7900H90026 MTA7900H90027 MTA7900H90028 MTA7900H90029 MTA7900H90030 MTA7900I90001 MTA7900I90002 MTA7900I90004 MTA7900I80027 MTA7900I80028 MTA7900J80014 MTA7900J80016 MTA7900C01004 MTA7900C01007 MTA7900C01022 MTA7900D01012 MTA7900J70015 MTA7900H80020 MTA7900B90004 MTA7900B90015 MTA7900I80026 MTA7900E01006 MTA7900E01009 MTA7900E01011 MTA7900E01012 MTA7900E01013 MTA7900D01026 MTA7900D01027 MTA7900F90026 MTA7900F01017 MTA7900F01030 MTA7900F01053 MTA7900D01021 MTA7900E01007 MTA7900E01008 MTA7900L80015 MTA7900L80016 MTA7900B80002 MTA7900E01039 MTA7900C90019 MTA7900D90022 MTA7900I80005 MTA7900J80037 MTA7900J80050 MTA7900J80052 MTA7900K90007 MTA7900K90010 MTA7900A90019 MTA7900A90021 MTA7900A90024 MTA7900A90026 MTA7900A90033 MTA7900A90022 MTA7900A01038 MTA7900A01039 MTA7900B90043 MTA7900L90008 MTA7900K90038 MTA7900K90041 MTA7900D01016 MTA7900D01017 MTA7900D01018 MTA7900D01020 MTA7900E80001 MTA7900I80023 MTA7900E90019 MTA7900K90025 MTA7900K90035 MTA7900K90044 MTA7900K90045 MTA7900K90046 MTA7900K90047 MTA7900K90048 MTA7900K90049 MTA7900K90050 MTA7900K90051 MTA7900K90052 MTA7900B90003 MTA7900B90005 MTA7900D90019 MTA7900D90023 MTA7900K90016 MTA7900K90017 MTA7900K90021 MTA7900K90023 MTA7900G90011 MTA7900G90014 MTA7900H80034 MTA7900I80001 MTA7900I80034 MTA7900B90024 MTA7900B90025  International Serial Numbers  MTA7900E01003 MTA7900H90003 MTA7900A90014 MTA7900A90015 MTA7900I90047 MTA7900I90049 MTA7900I90050 MTA7900I90051 MTA7900I90052 MTA7900J90001 MTA7900J90002 MTA7900J90003 MTA7900J90004 MTA7900J90006 MTA7900J90008 MTA7900J90009 MTA7900J90010 MTA7900A01022 MTA7900E01031 MTA7900E80003 MTA7900E80019 MTA7900F01047 MTA7900H80025 MTA7900H80041 MTA7900H80045 MTA7900I80004 MTA7900I80007 MTA7900I80008 MTA7900L70006 MTA7900L90019 MTA7900F01043
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    nationwide and worldwide
  • Descripción del producto
    The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the || Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. || The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA