Events

Retiro De Equipo (Recall) de Device Recall Medtronic Intersept Tubing Packs

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 Medtronic Inc. Cardiac Rhythm Disease Management.

¿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
    63769
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0618-2013
  • Fecha de inicio del evento
    2012-11-19
  • Fecha de publicación del evento
    2012-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114738
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    Medtronic is initiating an urgent medical device customer notification. we have confirmed that certain medtronic intersept tubing packs contain packaging trays that are susceptible to damage that can compromise product sterility.
  • Acción
    Medtronic sent a "Urgent Medical Device Customer Notification" letter dated November 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected product and to return affected product, but if they have concerns about replacement than they recommend to inspect and return any damaged product.. For further questions please contact your local Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. Outside the US, please call 1+763-526-7890. We apologize for any inconveniences this issue may have caused you or your institution.

Device

Device Recall Medtronic Intersept Tubing Packs
  • Modelo / Serial
    Pack Model Pack Lot 0E27R16- 11239917  11252800  11264666; 1A30R6- 12132577  12219267; 2493R24- 11187015  11199707  11224309  11227205  11556735; 2493R25- 11646941  11713200  11745242  11813334  11852673  11886412  11990393  12033630  12114699  12178107  12191642  12450856; 5D56R5- 11298229  11357085  11465358  11541270  11601193  11654853  11702415  11745232  11766305  11822320  11838721  11852677  11930380  12024708  12166379  12292156; 5Z93R4- 11713132  11736880  11749958  11766283  11808651  11860604  11878689  11911068  11948473 5Z93R5- 12236493;  12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801  12449801  12457250; 7P93R1- 12349795  12374420; 7Q11R1- 12344028  12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051  11315344  11334856  11489271  11745162  11886341  11977682  12019852  12062713  12098852  12139621  12146752  12258941  12277502  12326468  12421465  206110946;  CB5175R13- 11292866  11334859  11432873  11442937  12182778  12411655;  CB5Q03R6- 11713162  11766245  11787583  11923139  11934952;  CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501;  11813316  11838743  11869767  11908794  11982413  12019907  12146796  12151706  12201727  12292133  12423702; CB7C60R2- 11687047  11724030  11843434  11878672; CB7C74R2- 11895167; CB7D91R5- 11961280  12130493  12146882  12191604  12277455  12411687  12423760;  CB7E35R2- 11839101;  CB7E38R1- 11843886  11885844  11990360  12105025  12133083  12159400;  CB7G21R4- 12032413  12033728  12040524  12083359  12360622;  CB7L48R1- 12301694; CB7L72R1- 12155258; CB7P82R1- 12440601; HY6U96R2- 206133995; HY6Y52R2- 11826276; HY7E87R1- 11830948  11898103  11923498  12323794  12435409; SS7J91R3- 12175428; SSCB7L48R- 12120109; SSTL7G78R1 -11986264; TL5S33R7- 12093478;  12139612  12172589  12315375;  TL6V77R1- 11217931  11260111;  TL7B51R1- 11559097  11622968  11664762  11687063  11712834;  TL7G20R3- 12258680  12271138  12360554 TL7G78R3- 12067309; TL7R87R1- 206114578  206145379
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.
  • Descripción del producto
    Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: || 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. || Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 || Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA