Events

Retiro De Equipo (Recall) de Device Recall IV Start Kits

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 ICU Medical, 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
    60524
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0593-2012
  • Fecha de inicio del evento
    2011-03-01
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105695
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    The recall was initiated because icu medical inc. has become aware of the market recall of the triad group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by triad in the united states and marketed under various brand names. the triad alcohol prep pads have the potential contamination of the bacteria, bacillus cereus. the triad group alcohol prep pads have been copackaged a.
  • Acción
    The firm, ICU Medical, Inc., sent an "IMPORTANT-Important Information About Triad Group's Alcohol Prep Pads" letter dated March 2, 2011 (via email) to their distributors. Hard copy notices were shipped (via next day express delivery with receipt confirmation) to all their customers. The Important letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were informed that the Orbit and Orbit Micro subcutaneous infusion sets as well as the IV start kits are not contaminated and may continue to be used according to the directions for use. The issue is confined to the actual Triad alcohol prep pad products. Patients and healthcare providers should not use the alcohol prep pads packaged with these devices and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall. ICU Medical has halted all shipments of product that contain the Triad alcohol prep products to its distribution network. An alternate wipe has been qualified and is now being shipped in new orders. Customers were instructed to forward the Important letter to their customers and on to any end users of the devices. For Orbit and Orbit Micro devices, patients are instructed to immediately discontinue using the Triad alcohol prep pads included in the Orbit packaging and dispose of those pads in the trash. Patients should use an alternative prep pad that is not subject to the Triad recall. For IV Start Kits, distributors and users are instructed to place the enclosed label on the device prior to use. Additional labels can be obtained by contacting ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Standard time: (800) 866-9025 and select option 8, or email the following address: customerservice@icumed.com. Customers may also contact regulatory@icumed.com for MSWord template file for Avery 5160 labels and print additional labels. Customers were instructed to complete

Device

Device Recall IV Start Kits
  • Modelo / Serial
    Catalog # : Lot # B7825: 253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120, 253125, 253130, 253144, 253183, 253199, 253216, 253226,  253234, 253245, 253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341, 253348, 253363. B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC, 253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087, 253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133, 253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171,  253177, 253181, 253187, 253188, 253190, 253194, 253196 253198, 253200,  253205, 253207, 253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238, 253243, 253246, 253251, 253254, 253255, 253257, 253262,  253264, 253272, 253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299, 253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336, 253338, 253342, 253350, 253351, 253356, 253358,  253366, 253370, 253372, 253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401, 253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432, 253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470, 253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500, 253502, 253505, 253512, 253519, 857-SC4. B7841: 233163, 253028-SC, 253033-SC, 253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101, 253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156, 253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236, 253242, 253247,  253253, 253261, 253271, 253274, 253279, 253282, 253289, 253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333, 253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 , 253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425, 253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477, 253480, 253486, 253492, 253504, 253506, 253511, 253515,  253521, 253530. B7842: 20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142, 253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249, 253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380, 253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481, 253487, 253493, 253503, 253535. B7844: 253047-SC. B7846: 253513. B7905: 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226, 253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178, 253197, 253213, 253241, 253265, 253285, 253303,, 253310, 253325, 253337, 253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1. B7928: 213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC, 253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145, 253151, 253158, 253173, 253176, 253186, 253193, 253201,  253206, 253209, 253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260, 253268, 253277, 253287, 253291, 253296, 253306, 253312,  253317, 253323, 253330, 253334, 253340, 253345, 253349, 253353, 253359,  253368, 253371, 253382, 253389, 253393, 253398, 253404253408, 253416, 253424, 253429, 253433, 253442, 253448, 253454, 253460, 253464, 253471,  253478, 253483, 253488, 253494, 253497, 253501, 253507. B7932: 2010961, 2012567, 2012965, 2022800.  B7937: 253355, 253362, 253377, 253394.  B7938: 253354, 253361, 253378, 253395.  Z0125: 78-458-YJ.  Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5, 63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A, 69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5, 76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN, 92-782-R5, 94-196.2A, 94-196-2A  Z8017: 61-577-K4, 63-347-SN, 64-194-2A, 64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A, 81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5, 93-166-LA.  Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ, 64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (Nationwide) and countries of: Austria, Belgium, Chile, Cyprus, CZ, France, Germany, Great Britain, Greece, Israel, Italy, Lithuania, Netherland, Poland, Russia, Saudi Arabia, Sweden, and Switzerland.
  • Descripción del producto
    IV Start Kits || Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Dirección del fabricante
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673
  • Empresa matriz del fabricante (2017)
    ICU Medical, Inc.
  • Source
    USFDA