Events

Retiro De Equipo (Recall) de Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx

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 Cordis 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
    30826
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0555-05
  • Fecha de inicio del evento
    2004-11-18
  • Fecha de publicación del evento
    2005-02-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36664
  • 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
    Coronary Drug-Eluting Stent - Product Code NIQ
  • Causa
    Inventory control stickers had incorrect expiration date. the stickers stated the expiration date was november 2004 instead of october 2004.
  • Acción
    The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product.

Device

Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and C...
  • Modelo / Serial
    Lot # 50704127, 50804011, 40804419, 40804422, 40804454, 40904372, 50704295, X0704425, X0804127, X0904342, 40904373, A0804001, A0804816, X0904265, 40904407, X0704674, X0704943, A0804485, X0804498, A0804786, A0804849, 50704343, 50704422, X0704677, A0804002, A0904352, 50704126, A0804006, 40804658, 40904376, 50804311, 50804326, 40804467, X0804725, A0804846, 40904398, 50704344, A0804150, 50804168, X0804215, 40804453, X0904164, 40904400, A0904471, 40804200, A0904347, 40904409, A0904703, X0804723, A0804944, 50704423, 40804034, 50804211, 40804471, 40804477, 50804309, 40804433, X0804442, X0704098, 50704144, 50704282, 50704424, X0904073, A0904738, X0804214, A0804948, A0904349, 40904404, 40904413, A0904807, X0704825, A0904808, X0704961, 50804312, X0804370, 40804479, X0804495, A0804847, 40804201, X0804260, 40904369, 40904412, A0704263, 50704442, A0704528, 50804416, X0804724, A0804946, 40904350, 40904351, 50704446, X0704575, X0704826, 40804434, 40804465, 40804615, 40904375, X0604561, X0704819, 40804033, 40804202, 40804421, A0804486, X0904122, 40904378, A0904607, A0904701, 50704443, A0704629, X0704944, 40804431, 40804473, X0804496, 40904322, A0904348, 40904367, A0904476, A0904477, A0904720, A0904775, 50704125, X0704428, 50704441, X0704577, A0704631, 40804032, X0804126, X0804390, 40804472, A0904034, 40904321, 40904333, 40904334, 40904353, A0904696, X0704241, 50804313, 50804457, 40804659, A0804945, 40904379, A0904635, A0904636, 50704570, X0704964, A0804198, A0804203, X0804369, X0804392, 40804418, X0804630, A0804970, X0904121, 40904338, A0904483, A0904484, A0904488, X0704820, X0704945, A0804008, 50804165, 40804203, 50804417, 40804429, A0804568, X0804629, X0904119, X0904120, 40904339, 40904340, 40904374, A0904491, A0904492, 40904853, 50804166, A0804201, 40804432, 40804481, A0804567, X0804631, X0804882, 40904382, A0904719, A0904739, A0904876, 50704445, X0704821, X0804721, 40804913, 40904342, 40904365, A0904495, A0904707, A0904858, A0904875, A0804005, X0804086, 50804213, X0804722, 40904366, A0904497, A0904498, A0904736, A0904774, 40904854, X0704962, A0804004, A0804303, 40804437, A0904346, 40904368, A0904500, A0904860, A0704096, 50704366, 50704444, A0804009, 40904320, A0904698, A0904809, A0904859, 50704027, X0704307, A0804007, A0804149, 50804310, 40804430, X0804441, X0804497, 40904345, 40904364, A0904501, A0904699, X0704673, X0704824, A0804388, X0804689, X0804878, X0904237, 40904385, 50704425, X0704822, 50804418, 40804420, X0804690, A0804757, A0804817, 40904347, 40904348, X0704963, A0804199, A0804246, 40904354, 40904377, 40904386, A0904547.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed nation wide.
  • Descripción del producto
    Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Dirección del fabricante
    Cordis Corporation, 14201 NW 60th Ave, Miami Lakes FL 33014-2802
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA