Events

Retiro De Equipo (Recall) de Device Recall 60 mL Syringe w/Lateral Flow Needle

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 Mallinckrodt 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
    61187
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1122-2012
  • Fecha de inicio del evento
    2012-02-10
  • Fecha de publicación del evento
    2012-02-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107525
  • 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
    Injection and syringe, angirgraphic - Product Code DXT
  • Causa
    The machine used to package the product was missing a tool, which could prevent the packaging from sealing properly, causing the sterility of the product to be compromised.
  • Acción
    Covidien sent an Urgent Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product immediately. Customers were to use the attached business response form to report the quantity of each lot that is currently in their stock. If customers did not have any of these lots in stock, they should indicate by checking the appropriate box on the business report form. When completed, customers should email the completed form to covidien2600@stericycle.com or fax to 888-257-7910. For any questions customers should call 866-761-9571.

Device

Device Recall 60 mL Syringe w/Lateral Flow Needle
  • Modelo / Serial
    Catalog #: 801801; Lot #: 0008414, 0008415, 0015042, 0015043, 0022236, 0029499, 0029500, 0036252, 0036253, 0060075, 0064356, 0067043, 0071245, 0074027, 0078240, 0081116, 0085386, 0088170, 0095186, 0099109, 0102058, 0106079, 0109044, 0113426, 0120272, 0120472, 0123066, 0134341, 0141207, 0155153, 0155154, 0162123, 0235010, 0235011, 0246196, 0246197, 0260208, 0260209, 0300141, 0300142, 0309197, 0309198, 0316143, 0316144, 0316145, 0323181, 0337129, 0337130, 1007198, 1007199, 1007200, 1007201, 1021246, 1028228, 1028229, 1028230, 1028231, 1028232, 1035285, 1035286, 1035287, 1035288, 1042122, 1042123, 1049310, 1049311, 1049312, 1049313, 1056021, 1056022, 1063219, 1063220, 1070128, 1070129, 1084125, 1084126, 1091216, 1091217, 1098211, 1098212, 1105219, 1105220, 1119061, 1119062, 1119063, 1119064, 1147187, 1147188, 1154167, 1154168, 1217151, 1224177, 1231123, 1231124, 1238134, 1252133, 1252134, 1266175, 1266176, 1273129, 1273130, 1280130, 1280131, 1287134, 1287135, 1294121, 1294122, 1301131, 1301132, 1308138, 1315138, 1315139, 1322137, 1336335, 1336336, 1343177, 9023166, 9037138, 9037139, 9044170, 9044184, 9051152, 9051153, 9058256, 9058257, 9065164, 9065165, 9065448, 9072267, 9079179, 9079180, 9093273, 9093274, 9100261, 9100262, 9114150, 9114151, 9128089, 9128090, 9156194, 9156195, 9163187, 9163188, 9176144, 9176145, 9191020, 9191021, 9219142, 9219143, 9240131, 9240132, 9247098, 9247099, 9253017, 9253018, 9275101, 9275102, 9281033, 9281034, 9295029, 9295030, 9310048, 9310049, 9317055, 9317056, 9331148, 9331149, 9334065, 9338345, 9351119, 9352231, 9357639
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and Uruguay.
  • Descripción del producto
    Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim Company, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. || Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Dirección del fabricante
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA