Events

Retiro De Equipo (Recall) de Cordis PALMAZ Genesis on Aviator

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
    27450
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0567-04
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31725
  • 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
    Stent, Coronary - Product Code MAF
  • Causa
    A packaging defect may compromise the device's sterility barrier.
  • Acción
    The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 2004.

Device

Cordis PALMAZ Genesis on Aviator
  • Modelo / Serial
    New Lots with October 2003 or newer dating embedded in lot number (''1003'' MMYY in the second to fifth digit of Lot Number) and any older ones with a Green Dot indicating that they passed Cordis Inspection ARE NOT COVERED. The following previsouly uninspected lots were covered under the recall:   GENESIS ON AVIATOR ITEM_NO LOT_NO PG1240BAS R0102162 PG1240BAS R0103762 PG1240BAS R0303867 PG1240BAS R0402516 PG1240BAS R0502496 PG1240BAS R0603167 PG1240BAS R0702008 PG1240BAS R0902502 PG1240BAS R1002939 PG1240BAS R1101315 PG1240BAS S0202246 PG1240BAX R0102349 PG1240BAX R0402517 PG1240BAX R0502605 PG1240BAX R0503093 PG1240BAX R0603473 PG1240BAX R0702838 PG1240BAX R0902244 PG1240BAX R0902699 PG1240BAX S0502169 PG1240BAX S1101230 PG1245BAS R0102430 PG1245BAS R0102744 PG1245BAS R0302849 PG1245BAS R0402791 PG1245BAS R0702460 PG1245BAS R1102229 PG1245BAX R0103280 PG1245BAX R0502498 PG1245BAX R0603168 PG1245BAX R0902503 PG1245BAX S0402147 PG1250BAS R0103764 PG1250BAS R0103996 PG1250BAS R0202813 PG1250BAS R0303424 PG1250BAS R0403027 PG1250BAS R0502231 PG1250BAS R0602060 PG1250BAS R0603286 PG1250BAS R0702948 PG1250BAS R0902506 PG1250BAS R0902697 PG1250BAS R1002963 PG1250BAS R1201021 PG1250BAS R1201362 PG1250BAS R1201450 PG1250BAS S0202258 PG1250BAS S1001324 PG1250BAS S1001598 PG1250BAS S1001832 PG1250BAX R0203740 PG1250BAX R0302565 PG1250BAX R0303151 PG1250BAX R0402639 PG1250BAX R0403332 PG1250BAX R0503095 PG1250BAX R0603287 PG1250BAX R0702249 PG1250BAX R0703418 PG1250BAX R0802543 PG1250BAX R0802857 PG1250BAX R0902507 PG1250BAX R1002452 PG1250BAX R1002738 PG1250BAX R1102250 PG1250BAX S0502168 PG1250BAX S0802190 PG1255BAS R0102163 PG1255BAS R0203233 PG1255BAS R0302372 PG1255BAS R0303718 PG1255BAS R0702465 PG1255BAS S0202049 PG1255BAS S1001325 PG1255BAX R0203741 PG1255BAX R0402845 PG1255BAX R0403028 PG1255BAX R0502232 PG1255BAX R0603475 PG1255BAX R0702459 PG1255BAX R0702839 PG1255BAX R1002453 PG1255BAX R1102251 PG1255BAX S0102170 PG1260BAS R0103125 PG1260BAS R0303425 PG1260BAS R0402932 PG1260BAS R0403159 PG1260BAS R0502516 PG1260BAS R0503094 PG1260BAS R0503378 PG1260BAS R0603469 PG1260BAS R0702025 PG1260BAS R0702841 PG1260BAS R0802255 PG1260BAS R0902245 PG1260BAS R0902698 PG1260BAS R1002964 PG1260BAS R1101551 PG1260BAS R1102512 PG1260BAS R1201355 PG1260BAS R1201528 PG1260BAS R1201609 PG1260BAS R1202073 PG1260BAS R1202173 PG1260BAS S0103005 PG1260BAS S0203004 PG1260BAS S1002213 PG1260BAS S1101666 PG1260BAX R0102428 PG1260BAX R0203234 PG1260BAX R0203742 PG1260BAX R0302645 PG1260BAX R0303152 PG1260BAX R0303868 PG1260BAX R0403609 PG1260BAX R0403825 PG1260BAX R0502227 PG1260BAX R0503096 PG1260BAX R0503514 PG1260BAX R0602061 PG1260BAX R0602862 PG1260BAX R0702467 PG1260BAX R0703155 PG1260BAX R0902021 PG1260BAX R0902165 PG1260BAX R1002173 PG1260BAX R1002296 PG1260BAX R1002680 PG1260BAX R1102252 PG1260BAX S0102414 PG1260BAX S0203005 PG1260BAX S0602042 PG1265BAS R0403330 PG1265BAS R0502831 PG1265BAS S1002280 PG1265BAX R0103481 PG1265BAX R0303714 PG1265BAX R0702009 PG1265BAX R0703355 PG1265BAX R0902246 PG1265BAX S0402103 PG1270BAS R0203744 PG1270BAS R0303716 PG1270BAS R0502160 PG1270BAS R1002714 PG1270BAS R1102004 PG1270BAS R1102253 PG1270BAS S0402106 PG1270BAX R0103480 PG1270BAX R0303460 PG1270BAX R0403823 PG1270BAX R0702023 PG1270BAX R0802631 PG1270BAX R1102300 PG1540BAS R0102006 PG1540BAS R0702452 PG1540BAS R1101267 PG1540BAS R1101821 PG1540BAS R1201529 PG1540BAS S1001301 PG1540BAX R0103278 PG1540BAX R0203492 PG1540BAX R0303423 PG1540BAX R0402640 PG1540BAX R0603165 PG1540BAX R1002186 PG1540BAX R1101931 PG1540BAX S0102413 PG1540BAX S0802196 PG1540BAX S1101115 PG1545BAS R0103763 PG1545BAS R0802391 PG1545BAS R1002454 PG1545BAS R1101083 PG1545BAS R1202072 PG1545BAS S0102167 PG1545BAS S0102412 PG1545BAX R0603166 PG1545BAX R1201958 PG1545BAX S0203003 PG1545BAX S0302251 PG1545BAX S1101026 PG1550BAS R0102240 PG1550BAS R0203235 PG1550BAS R0303869 PG1550BAS R0403328 PG1550BAS R0602266 PG1550BAS R0602802 PG1550BAS R0603470 PG1550BAS R0802256 PG1550BAS R0802544 PG1550BAS R0902535 PG1550BAS R0902773 PG1550BAS R1101088 PG1550BAS R1101172 PG1550BAS R1101175 PG1550BAS R1101265 PG1550BAS R1101351 PG1550BAS R1101532 PG1550BAS R1101819 PG1550BAS R1201449 PG1550BAS R1201521 PG1550BAS R1201522 PG1550BAS S0102209 PG1550BAS S0203008 PG1550BAS S1001450 PG1550BAS S1001687 PG1550BAS S1101288 PG1550BAX R0203236 PG1550BAX R0203416 PG1550BAX R0303200 PG1550BAX R0303916 PG1550BAX R0402732 PG1550BAX R0403329 PG1550BAX R0502099 PG1550BAX R0503139 PG1550BAX R0503149 PG1550BAX R0503515 PG1550BAX R0503936 PG1550BAX R0702649 PG1550BAX R0702676 PG1550BAX R0802545 PG1550BAX R0902187 PG1550BAX R0902695 PG1550BAX R1101113 PG1550BAX S0102270 PG1550BAX S0202010 PG1550BAX S0502275 PG1550BAX S0802192 PG1550BAX S0902086 PG1550BAX S1002215 PG1555BAS R0102164 PG1555BAS R0102274 PG1555BAS R0203237 PG1555BAS R0303018 PG1555BAS R0503516 PG1555BAS R0602463 PG1555BAS R1201022 PG1555BAS R1201361 PG1555BAS R1201411 PG1555BAS S0602038 PG1555BAX R0203238 PG1555BAX R0303131 PG1555BAX R0503140 PG1555BAX R0802858 PG1555BAX R1002189 PG1555BAX R1201959 PG1555BAX S0502225 PG1555BAX S1001685 PG1555BAX S1001884 PG1560BAS R0103477 PG1560BAS R0103765 PG1560BAS R0203239 PG1560BAS R0203745 PG1560BAS R0302329 PG1560BAS R0302566 PG1560BAS R0303426 PG1560BAS R0303715 PG1560BAS R0403610 PG1560BAS R0502211 PG1560BAS R0503314 PG1560BAS R0503517 PG1560BAS R0702026 PG1560BAS R0702479 PG1560BAS R0702507 PG1560BAS R0702651 PG1560BAS R0703196 PG1560BAS R0902247 PG1560BAS R0902476 PG1560BAS R0902826 PG1560BAS R1101997 PG1560BAS R1102513 PG1560BAS R1201050 PG1560BAS R1201524 PG1560BAS S0402010 PG1560BAS S0402185 PG1560BAS S1001425 PG1560BAS S1001427 PG1560BAS S1001451 PG1560BAS S1001496 PG1560BAS S1001829 PG1560BAS S1002017 PG1560BAS S1002274 PG1560BAS S1101059 PG1560BAS S1101664 PG1560BAX R0102745 PG1560BAX R0103767 PG1560BAX R0203240 PG1560BAX R0203417 PG1560BAX R0302591 PG1560BAX R0302899 PG1560BAX R0303530 PG1560BAX R0303928 PG1560BAX R0403132 PG1560BAX R0403821 PG1560BAX R0502210 PG1560BAX R0503150 PG1560BAX R0503315 PG1560BAX R0503710 PG1560BAX R0602005 PG1560BAX R0603097 PG1560BAX R0702027 PG1560BAX R0702439 PG1560BAX R0702677 PG1560BAX R0802390 PG1560BAX R0802862 PG1560BAX R0902827 PG1560BAX R1002735 PG1560BAX R1102301 PG1560BAX R1102514 PG1560BAX R1202286 PG1560BAX S0102002 PG1560BAX S0102169 PG1560BAX S0802193 PG1560BAX S0902003 PG1560BAX S1001123 PG1565BAS R0103478 PG1565BAS R0303457 PG1565BAS R0502101 PG1565BAS R0703218 PG1565BAS R1002053 PG1565BAS S0402104 PG1565BAX R0103479 PG1565BAX R0303201 PG1565BAX R0502212 PG1565BAX R0702842 PG1565BAX R0703219 PG1565BAX R0802132 PG1565BAX S0402105 PG1570BAS R0103768 PG1570BAS R0203746 PG1570BAS R0303717 PG1570BAS R0502229 PG1570BAS R0603311 PG1570BAS R0603645 PG1570BAS R1002232 PG1570BAS R1002940 PG1570BAS R1202043 PG1570BAS R1202322 PG1570BAS S0402141 PG1570BAS S0402253 PG1570BAX R0103126 PG1570BAX R0303531 PG1570BAX R0403612 PG1570BAX R0502178 PG1570BAX R0503317 PG1570BAX R0603101 PG1570BAX R0802859 PG1570BAX R0902504 PG1570BAX S0103010 PG1570BAX S0303010 PG1570BAX S0402142 PG1570BAX S0502033 PG1570BAX S0602043 PG1570BAX S0902002 PG1840BAS R0502497 PG1840BAS R1101681 PG1840BAS S0302252 PG1840BAS S1001322 PG1840BAS S1001497 PG1840BAS S1001498 PG1840BAS S1001883 PG1840BAS S1101431 PG1840BAX R0303158 PG1840BAX R0403658 PG1840BAX R0603212 PG1840BAX R0603285 PG1840BAX R0702010 PG1840BAX R0902188 PG1840BAX S1101027 PG1845BAS R0203493 PG1845BAS R1102533 PG1845BAS S0202255 PG1845BAS S0302253 PG1845BAS S1001302 PG1845BAX R0102662 PG1845BAX R0402792 PG1845BAX R0902828 PG1845BAX R1002739 PG1845BAX R1101316 PG1850BAS R0103770 PG1850BAS R0302223 PG1850BAS R0303157 PG1850BAS R0303927 PG1850BAS R0502955 PG1850BAS R0503151 PG1850BAS R0602267 PG1850BAS R0603005 PG1850BAS R0702453 PG1850BAS R0702466 PG1850BAS R1101003 PG1850BAS R1101352 PG1850BAS R1101680 PG1850BAS R1101820 PG1850BAS S0102474 PG1850BAS S0103004 PG1850BAS S0202051 PG1850BAS S0302287 PG1850BAS S1001094 PG1850BAS S1001424 PG1850BAS S1001686 PG1850BAS S1101133 PG1850BAX R0102348 PG1850BAX R0103997 PG1850BAX R0203418 PG1850BAX R0303155 PG1850BAX R0303690 PG1850BAX R0402733 PG1850BAX R0503141 PG1850BAX R0503623 PG1850BAX R0503711 PG1850BAX R0602240 PG1850BAX R0802051 PG1850BAX R0802546 PG1850BAX R0802860 PG1850BAX R0902248 PG1850BAX R1002462 PG1850BAX R1002736 PG1850BAX R1102534 PG1850BAX R1202321 PG1850BAX S0402148 PG1850BAX S0502242 PG1850BAX S0802194 PG1850BAX S0902010 PG1850BAX S1001122 PG1850BAX S1101228 PG1855BAS R0102918 PG1855BAS R0303019 PG1855BAS R0303458 PG1855BAS R0603308 PG1855BAS R0603643 PG1855BAS S0602039 PG1855BAS S1001499 PG1855BAS S1001600 PG1855BAS S1001833 PG1855BAS S1001834 PG1855BAX R0302592 PG1855BAX R0402113 PG1855BAX R0403824 PG1855BAX R0902167 PG1855BAX S0302302 PG1855BAX S0502034 PG1855BAX S1101028 PG1860BAS R0103037 PG1860BAS R0103397 PG1860BAS R0103482 PG1860BAS R0203743 PG1860BAS R0303459 PG1860BAS R0303691 PG1860BAS R0403327 PG1860BAS R0502230 PG1860BAS R0503712 PG1860BAS R0602052 PG1860BAS R0602461 PG1860BAS R0603019 PG1860BAS R0603310 PG1860BAS R0702028 PG1860BAS R0702440 PG1860BAS R0902505 PG1860BAS R1002194 PG1860BAS R1101171 PG1860BAS R1101550 PG1860BAS R1101998 PG1860BAS R1102535 PG1860BAS R1201020 PG1860BAS S0102043 PG1860BAS S0103006 PG1860BAS S0302320 PG1860BAS S0402078 PG1860BAS S0502144 PG1860BAS S1001095 PG1860BAS S1001323 PG1860BAS S1001782 PG1860BAS S1002281 PG1860BAS S1101575 PG1860BAX R0103277 PG1860BAX R0103771 PG1860BAX R0202115 PG1860BAX R0202729 PG1860BAX R0203419 PG1860BAX R0402114 PG1860BAX R0403079 PG1860BAX R0403611 PG1860BAX R0502228 PG1860BAX R0503142 PG1860BAX R0503152 PG1860BAX R0503518 PG1860BAX R0503934 PG1860BAX R0603476 PG1860BAX R0702024 PG1860BAX R0702441 PG1860BAX R0702506 PG1860BAX R0802257 PG1860BAX R0902991 PG1860BAX R1002463 PG1860BAX R1002737 PG1860BAX R1102536 PG1860BAX S0103009 PG1860BAX S0303009 PG1860BAX S0402150 PG1860BAX S0802195 PG1860BAX S1001124 PG1860BAX S1002018 PG1860BAX S1101229 PG1865BAS R0303020 PG1865BAS R0502711 PG1865BAS R0602537 PG1865BAS R0703220 PG1865BAS R1202320 PG1865BAX R0602062 PG1865BAX R0703221 PG1865BAX R0802052 PG1865BAX R0902166 PG1870BAS R0103042 PG1870BAS R0203491 PG1870BAS R0403215 PG1870BAS R0502159 PG1870BAS R0502209 PG1870BAS R0603313 PG1870BAS R0703691 PG1870BAS R1102537 PG1870BAS R1202044 PG1870BAS S0402143 PG1870BAX R0103769 PG1870BAX R0303532 PG1870BAX R0403331 PG1870BAX R0502956 PG1870BAX R0503155 PG1870BAX R0503760 PG1870BAX R0802861 PG1870BAX R0803115 PG1870BAX R0902969 PG1870BAX R1102302 PG1870BAX S0402144 PG2440BAS R0102241 PG2440BAS R1101930 PG2440BAX R0102661 PG2440BAX S0102168 PG2440BAX S0302321 PG2450BAS R0302747 PG2450BAS R0603637 PG2450BAS R1101268 PG2450BAS S0102044 PG2450BAS S1101025 PG2450BAX R0102431 PG2450BAX R0402759 PG2450BAX R0503939 PG2450BAX R0602147 PG2450BAX R0703462 PG2460BAS R0503713 PG2460BAS R0703043 PG2460BAS R1101269 PG2460BAS R1201957 PG2460BAS S1101533 PG2460BAX R0302968 PG2460BAX R0403213 PG2460BAX R0503519 PG2460BAX R0602539 PG2460BAX R0603315 PG2460BAX R0703463 PG2460BAX R0802054 PG2460BAX R0902249 PG2470BAS R0502205 PG2470BAS S0303011 PG2470BAS S0402145 PG2470BAX R0502179 PG2470BAX R0503788 PG2470BAX R0902475 PG2470BAX R0902696 PG2470BAX S0402146
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed nationwide to 1035 domestic hospital accounts no international, government or military accounts.
  • Descripción del producto
    This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULAR Lot No. Use By Cordis Europa N.V. 9301 LJ Roden The Netherlands STERILE Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Dirección del fabricante
    Cordis Corporation, 14201 N.W. 60th Ave, Miami Lakes FL 33014
  • Source
    USFDA