Events

Retiro De Equipo (Recall) de Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters

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 Ethicon Endo-Surgery Inc.

¿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
    59764
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3187-2011
  • Fecha de inicio del evento
    2011-07-29
  • Fecha de publicación del evento
    2011-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103610
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Ethicon endo-surgery initiated a voluntary global recall for specific production lots of endopath¿ ets compact flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.
  • Acción
    Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.

Device

Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters
  • Modelo / Serial
    Model # CTS45  Lot # F4PD36, Exp Date Jul-2014; Lot # F4PD9U, Exp Date Jul-2014; Lot # F4PG0X, Exp Date Aug-2014; Lot #, F4PG42, Exp Date Aug-2014; Lot # F4PG92, Exp Date Aug-2014; Lot # F4PH1N, Exp Date Aug-2014; Lot # F4PH4N, Exp Date Aug-2014; Lot # F4PJ4U, Exp Date Aug-2014; Lot # F4PK4W, Exp Date Aug-2014; Lot # F4PM4R, Exp Date Sep-2014; Lot # F4PM61, Exp Date Sep-2014; Lot # F4PN2E, Exp Date Sep-2014; Lot # F4PN8Z, Exp Date Sep-2014; Lot # F4PP1A, Exp Date Sep-2014; Lot # F4PP9F, Exp Date Sep-2014; Lot # F4PR1V, Exp Date Sep-2014; Lot # F4PU0Y, Exp Date Sep-2014; Lot # F4PU6Y, Exp Date Sep-2014; Lot # F4PV1E, Exp Date Oct-2014; Lot # F4PW2Z, Exp Date Oct-2014; Lot # F4PX14, Exp Date Oct-2014; Lot # F4PX5J, Exp Date Oct-2014; Lot # F4PX81, Exp Date Oct-2014; Lot # F4PY36, Exp Date Oct-2014; Lot # F4PY9W, Exp Date Oct-2014; Lot # F4PZ7L, Exp Date Oct-2014; Lot # F4PZ9H, Exp Date Oct-2014; Lot # F4R11D, Exp Date Nov-2014; Lot # F4R14L, Exp Date Nov-2014; Lot # F4R172, Exp Date Nov-2014; Lot # F4R213, Exp Date Nov-2014; Lot # F4R299, Exp Date Nov-2014; Lot # F4R31F, Exp Date Nov-2014; Lot # F4R435, Exp Date Nov-2014; Lot # F4R45U, Exp Date Nov-2014; Lot # G4R54T, Exp Date Dec-2014; Lot # G4R81J, Exp Date Dec-2014; Lot # G4R823, Exp Date Dec-2014; Lot # G4R971, Exp Date Dec-2014; Lot # G4R97A, Exp Date Dec-2014; Lot # G4R99A, Exp Date Dec-2014; Lot # G4RD0H, Exp Date Jan-2015; Lot # G4RD6P, Exp Date Jan-2015; Lot # G4RE6K, Exp Date Jan-2015; Lot # G4RG45, Exp Date Jan-2015; Lot # G4RG7C, Exp Date Jan-2015; Lot # G4RH07, Exp Date Jan-2015; Lot # G4RH1E, Exp Date Jan-2015; Lot # G4RL49, Exp Date Feb-2015; Lot # G4RM0M, Exp Date Feb-2015; Lot # G4RN6U, Exp Date Feb-2015; Lot # G4RN81, Exp Date Feb-2015; Lot # G4RP03, Exp Date Feb-2015; Lot # G4RP4M, Exp Date Feb-2015; Lot # G4RP8C, Exp Date Feb-2015; Lot # G4RR9N, Exp Date Feb-2015; Lot # G4RT2F, Exp Date Feb-2015; Lot # G4RT7H, Exp Date Feb-2015; Lot # G4RU9U, Exp Date Mar-2015; Lot # G4RV45, Exp Date Mar-2015; Lot # G4RV6G, Exp Date Mar-2015; Lot # G4RV95, Exp Date Mar-2015; Lot # G4RW0J, Exp Date Mar-2015; Lot # G4RX6X, Exp Date Mar-2015; Lot # G4RY1G, Exp Date Mar-2015; Lot # G4RY2D, Exp Date Mar-2015; Lot # G4RY4N, Exp Date Mar-2015; Lot # G4RZ1U, Exp Date Mar-2015; Lot # G4T04U, Exp Date Apr-2015; Lot # G4T099, Exp Date Apr-2015; Lot # G4T12L, Exp Date Apr-2015; Lot # G4T159, Exp Date Apr-2015; Lot # G4T39L, Exp Date Apr-2015; Lot # G4T43Y, Exp Date Apr-2015; Lot # G4T48N, Exp Date Apr-2015; Lot # G4T553, Exp Date Apr-2015; Lot # G4T59H, Exp Date Apr-2015; Lot # G4T86K, Exp Date May-2015; Lot # G4T92W, Exp Date May-2015; Lot # G4T96N, Exp Date May-2015; Lot # G4TA3E, Exp Date May-2015; Lot # G4TC5W, Exp Date May-2015; Lot # G4TC82, Exp Date May-2015; Lot # G4TE91, Exp Date Jun-2015; Lot # G4TG0U, Exp Date Jun-2015; Lot # G4TK3C, Exp Date Jun-2015; Lot # G4TK5X, Exp Date Jun-2015; Lot # G4TL66, Exp Date Jul-2015; Lot # G4TL6N, Exp Date Jul-2015; Lot # G4TM1L, Exp Date Jul-2015; Lot # G4TN19, Exp Date Jul-2015; Lot # G4TN5F, Exp Date Jul-2015; Lot # G4TP0Y, Exp Date Jul-2015; Lot # G4TP51, Exp Date Jul-2015; Lot # G4TP88, Exp Date Jul-2015; Lot # G4TR5K, Exp Date Jul-2015 Lot # G4TR9T, Exp Date Jul-2015; Lot # G4TT8Z, Exp Date Jul-2015; Lot # G4TU1G, Exp Date Aug-2015; Lot # G4TU1J, Exp Date Aug-2015; Lot # G4TV44, Exp Date Aug-2015; Lot # G4TX08, Exp Date Aug-2015; Lot # G4TX3H, Exp Date Aug-2015; Lot # G4TZ93, Exp Date Aug-2015; Lot # G4U020, Exp Date Aug-2015; Lot # G4U10D, Exp Date Sep-2015; Lot # G4U13F, Exp Date Sep-2015; Lot # G4U19A, Exp Date Sep-2015; Lot # G4U22Z, Exp Date Sep-2015; Lot # G4U28H, Exp Date Sep-2015; Lot # G4U51C, Exp Date Sep-2015; Lot # G4U62P, Exp Date Sep-2015; Lot # G4U62V, Exp Date Sep-2015; Lot # G4U83X, Exp Date Oct-2015; Lot # G4U91N, Exp Date Oct-2015; Lot # G4U94C, Exp Date Oct-2015; Lot # G4UA7G, Exp Date Oct-2015; Lot # G4UC07, Exp Date Oct-2015; Lot # G4UC4D, Exp Date Oct-2015; Lot # G4UC88, Exp Date Oct-2015; Lot # G4UD43, Exp Date Oct-2015; Lot # G4UD5C, Exp Date Oct-2015; Lot # G4UG3F, Exp Date Nov-2015; Lot # G4UG3J, Exp Date Nov-2015; Lot # G4UG82, Exp Date Nov-2015; Lot # G4UH9L, Exp Date Nov-2015; Lot # H4315X, Exp Date Dec-2015; Lot # H4317R, Exp Date Dec-2015; Lot # H4320H, Exp Date Dec-2015; Lot # H43303, Exp Date Dec-2015; Lot # H43369, Exp Date Dec-2015; Lot # H43409, Exp Date Dec-2015; Lot # H43436, Exp Date Dec-2015; Lot # H4351F, Exp Date Dec-2015; Lot # H43914, Exp Date Jan-2016; Lot # H43966, Exp Date Jan-2016; Lot # H43985, Exp Date Jan-2016; Lot # H43A2A, Exp Date Jan-2016; Lot # H43A4W, Exp Date Jan-2016; Lot # H43C68, Exp Date Jan-2016; Lot # H43E38, Exp DateFeb-2016; Lot # H43F4A, Exp Date Feb-2016; Lot # H43F6N, Exp Date Feb-2016; Lot # H43H3M, Exp Date Feb-2016; Lot # H43H64, Exp Date Feb-2016; Lot # H43H8J, Exp Date Feb-2016; Lot # H43J4N, Exp Date Feb-2016; Lot # H43M40, Exp Date Mar-2016; Lot # H43N4D, Exp Date Mar-2016; Lot # H43N5P, Exp Date Mar-2016; Lot # H43P11, Exp Date Mar-2016; Lot # H43R8Y, Exp Date Apr-2016; Lot # H43T5E, Exp Date Apr-2016; Lot # H43U8W, Exp Date Apr-2016; Lot # H43V5H, Exp Date Apr-2016; Lot # H43W06, Exp Date Apr-2016; Lot # H43W6C, Exp Date Apr-2016; Lot # H4402J, Exp Date May-2016; Lot # H4404X, Exp Date May-2016; Lot # H44303, Exp Date May-2016; Lot # H44369, Exp Date Jun-2016; Lot # H44604, Exp Date Jun-2016 and Lot # H4465K, Exp Date Jun-2016.   Model # CTS45NK  Lot # G4TZ37, Exp Date Aug-2015; Lot # G4UC08, Exp Date Oct-2015; Lot # H43A10, Exp Date Jan-2016 and Lot # H43W25, Exp Date Apr-2016.  Model # 6CB45  Lot # F4PE3Z, Exp Date Aug-2014; Lot # F4PH99, Exp Date Aug-2014; Lot # F4PR04, Exp Date Sep-2014; Lot # F4PX54, Exp Date Oct-2014; Lot # F4R204, Exp Date Nov-2014; Lot # G4R554, Exp Date Dec-2014; Lot # G4RD0F, Exp Date Jan-2015; Lot # G4RF4W, Exp Date Jan-2015; Lot # G4RJ23, Exp Date Jan-2015; Lot # G4RJ4D, Exp Date Jan-2015; Lot # G4RM6R, Exp Date Feb-2015; Lot # G4RR8N, Exp Date Feb-2015; Lot # G4RT26, Exp Date Feb-2015; Lot # G4RV11, Exp Date Mar-2015; Lot # G4RW1U, Exp Date Mar-2015; Lot # G4TJ4J, Exp Date Jun-2015; Lot # G4TN2N, Exp Date Jul-2015; Lot # G4TV1Z, Exp Date Aug-2015; Lot # G4UA7F, Exp Date Oct-2015; Lot # G4UC4C, Exp Date Oct-2015; Lot # H4345P, Exp Date Dec-2015 and Lot # H43L03, Exp Date Mar-2016.  Model # SCB45  Lot # F4PE3E, Exp Date Aug-2014; Lot # F4PL2N, Exp Date Aug-2014; Lot # F4PL31, Exp Date Sep-2014; Lot # F4PU2W, Exp Date Sep-2014 and Lot # F4PV36, Exp Date Oct-2014.  Model # SCG45  Lot # F4PL3M, Exp Date Sep-2014; Lot # F4PU2X, Exp Date Sep-2014; Lot # F4PX78, Exp Date Oct-2014; Lot # G4R72N, Exp Date Dec-2014; Lot # G4RC02, Exp Date Dec-2014; Lot # G4RJ3X, Exp Date Jan-2015; Lot # G4RL3U, Exp Date Feb-2015; Lot # G4RW9M, Exp Date Mar-2015; Lot # G4TC56, Exp Date May-2015; Lot # G4TR5C, Exp Date Jul-2015; Lot # G4UD5R, Exp Date Oct-2015; Lot # H43753, Exp Date Jan-2016; Lot # H43E0M, Exp Date Feb-2016 and Lot # H43L83, Exp Date Mar-2016.  Model # SCW45  Lot # F4PD3H, Exp Date Jul-2014; Lot # F4PE5V, Exp Date Aug-2014; Lot # F4PF5T, Exp Date Aug-2014; Lot # F4PL3P, Exp Date Sep-2014; Lot # F4PM1H, Exp Date Sep-2014; Lot # F4PU40, Exp Date Sep-2014; Lot # F4PV44, Exp Date Oct-2014; Lot # F4PW81, Exp Date Oct-2014; Lot # F4R15T, Exp Date Nov-2014; Lot # F4R27D, Exp Date Nov-2014; Lot # F4R352, Exp Date Nov-2014; Lot # G4R69T, Exp Date Dec-2014; Lot # G4R809, Exp Date Dec-2014; Lot # G4RC03, Exp Date Dec-2014; Lot # G4RF2X, Exp Date Jan-2015; Lot # G4RJ4K, Exp Date Jan-2015; Lot # G4RL44, Exp Date Feb-2015; Lot # G4RM75, Exp Date Feb-2015; Lot # G4RP7N, Exp Date Feb-2015; Lot # G4RU54, Exp Date Mar-2015; Lot # G4RX1E, Exp Date Mar-2015; Lot # G4RX62, Exp Date Mar-2015; Lot # G4T14R, Exp Date Apr-2015; Lot # G4T63F, Exp Date Apr-2015; Lot # G4TA7E, Exp Date May-2015; Lot # G4TF2K, Exp Date Jun-2015; Lot # G4TM93, Exp Date Jul-2015; Lot # G4TX42, Exp Date Aug-2015; Lot # G4U04J, Exp Date Sep-2015; Lot # G4U164, Exp Date Sep-2015; Lot # G4U74G, Exp Date Oct-2015; Lot # G4UA6K, Exp Date Oct-2015; Lot # H4305X, Exp Date Dec-2015; Lot # H4324F, Exp Date Dec-2015; Lot # H4329P, Exp Date Dec-2015; Lot # H43755, Exp Date Jan-2016; Lot # H43C2U, Exp Date Jan-2016; Lot # H43H0K, Exp Date Feb-2016; Lot # H43M8E, Exp Date Mar-2016; Lot # H43R6T, Exp Date Apr-2016 and Lot # H4406Z, Exp Date May-2016.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREECE, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, POLAND, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, THAILAND and UNITED ARAB EMIRATES
  • Descripción del producto
    ENDOPATH¿ ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 || The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA