Events

Retiro De Equipo (Recall) de Direct Drive Clip Applier

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 Applied Medical Resources Corp.

¿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
    73737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1621-2016
  • Fecha de inicio del evento
    2016-04-01
  • Fecha de publicación del evento
    2016-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144839
  • 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
    Clip, implantable - Product Code FZP
  • Causa
    Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
  • Acción
    Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60698158@appliedmedical.com or faxing to (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.com.

Device

Direct Drive Clip Applier
  • Modelo / Serial
    CA090 Direct Drive Clip Applier Lots: 1190181 to 1265006  Kit Lots (containing CA090 Direct Drive Clip Applier recalled lot(s)): 1247881 1252438 1255011 1257686 1261514 1263870 1265289 1248696 1254259 1262161 1262467 1241744 1242506 1241942 1242530 1244945 1246374 1247757 1248255 1248753 1251538 1254642 1256360 1265424 1266435 1241831 1242149 1242700 1244651 1244720 1244857 1246492 1246909 1247486 1248756 1251861 1257536 1258435 1261116 1266358 1243272 1234619 1235710 1237695 1238548 1238846 1240793 1244468 1246491 1247651 1247655 1248775 1250498 1250581 1255478 1257218 1258823 1262556 1264157 1238840 1242936 1245022 1245534 1248456 1251192 1252437 1252548 1230056 1235603 1234727 1235922 1237439 1238326 1238403 1238545 1238839 1239478 1240334 1225992 1233274 1235045 1235785 1235914 1237299 1238555 1240591 1249603 1251343 1253126 1255634 1257818 1260397 1263662 1225996 1237442 1237866 1238404 1238477 1238547 1239373 1239475 1239693 1239787 1240084 1252145 1255075 1255630 1256446 1257220 1258017 1258726 1260294 1261907 1263948 1226411 1236219 1241391 1242529 1243974 1244946 1248224 1226407 1235931 1237674 1242254 1243047 1243791 1243891 1249850 1256895 1259667 1259851 1219268 1221879 1225510 1227601 1231153 1232472 1234612 1235932 1237776 1237685 1237613 1241065 1243412 1248933 1252254 1258822 1262980 1263752 1221402 1224448 1225688 1228275 1229519 1231540 1233085 1237208 1208179 1212899 1218330 1220676 1224025 1226700 1228640 1231752 1235420 1235933 1237446 1238957 1244715 1248930 1260050 1262974 1207582 1211964 1213348 1215655 1220773 1224677 1225541 1229358 1229814 1232136 1235934 1237296 1237441 1238664 1241637 1245210 1249328 1250670 1252542 1255884 1258623 1208188 1214348 1215395 1217487 1220675 1222617 1224446 1225988 1229518 1232390 1237297 1202209 1219277 1220672 1222920 1228476 1231546 1234608 1235936 1236369 1237554 1237672 1240275 1244243 1246668 1248037 1250377 1250501 1254776 1255888 1258022 1259190 1200914 1206845 1209215 1212044 1214049 1216162 1218416 1221878 1225800 1229460 1232826 1235938 1236216 1237295 1238236 1242167 1244242 1248752 1251667 1253795 1255249 1256453 1258724 1262463 1264978 1239115 1240081 1241438 1245356 1250585 1257053 1257013 1259850 1261795 1262978 1265587 1205249 1209889 1210208 1216023 1219162 1222616 1226412 1228911 1231372 1237223 1238955 1242165 1244482 1257050 1258111 1259752 1265423 1266357 1197820 1215518 1220501 1227361 1236505 1237556 1238231 1239176 1239372 1239476 1240466 1242381 1242603 1243024 1243107 1244464 1245535 1247170 1248861 1251285 1255471 1258827 1261229 1261635 1263312 1213257 1229194 1233224 1235167 1235786 1235926 1239090 1197347 1200503 1204271 1205245 1206848 1208641 1210614 1213259 1216465 1218090 1221793 1224444 1226054 1228176 1231545 1235921 1235939 1236683 1238053 1241380 1244571 1248041 1248261 1250175 1252541 1254960 1258622 1261515 1263240 1264598 1265733 1202994 1213882 1215926 1221877 1223688 1228643 1235043 1235165 1235604 1237303 1237221 1240736 1242932 1248750 1250582 1255277 1202967 1205019 1207404 1213750 1216024 1219610 1221876 1223078 1226705 1227362 1229822 1230908 1232137 1237215 1237673 1238162 1242160 1245086 1245532 1248774 1251868 1254562 1255821 1258020 1260551 1263047 1266169 1199152 1203027 1205033 1208643 1210720 1213631 1216771 1222034 1224235 1228109 1228366 1230062 1232336 1235940 1235693 1237786 1238327 1241740 1243531 1248045 1248331 1254641 1258903 1263120 1263786 1264975 1197346 1199421 1201836 1203217 1203748 1205246 1208185 1211548 1214352 1216981 1218211 1222615 1225700 1225797 1234093 1235941 1236682 1237775 1238056 1240394 1242384 1245657 1248254 1249151 1252440 1255072 1256890 1258804 1260757 1261909 1265195 1201735 1203344 1206923 1209888 1210504 1216625 1218415 1223570 1227798 1230299 1235942 1236215 1237772 1237555 1239948 1242035 1243790 1249001 1250576 1253900 1255633 1256561 1261405 1263239 1265435 1199151 1201225 1202109 1203470 1205783 1207472 1208536 1211599 1213970 1215814 1220499 1223001 1226528 1230295 1233400 1235943 1237220 1238161 1240270 1242770 1242933 1246669 1250583 1252946 1254708 1254712 1258429 1260650 1263241 1265189
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia
  • Descripción del producto
    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. || Distributed individually and in kits.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA