Events

Retiro De Equipo (Recall) de Device Recall Weck

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 Telefelx Medical.

¿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
    49452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0156-2009
  • Fecha de inicio del evento
    2008-08-22
  • Fecha de publicación del evento
    2008-09-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73452
  • 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
    Implantable clip - Product Code FZP
  • Causa
    A hole in the sterile unit blister pack was detected that would compromise sterility.
  • Acción
    Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks from the second mailing. Consignees also may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Upon return to Teleflex Medical, product will be quarantined, assessed for recall effectiveness, and either reworked or destroyed. Contact Telefex Medical at 1-800-334-9751 ext. 8066 for assistance.

Device

Device Recall Weck
  • Modelo / Serial
    Product manufactured from January 2006 through July 2008; Product Description: HEMOCLIP MEDIUM 250/BOX, Product Code: 523100, Lot number: 01C0800066, 01D0800156, 01D0800324, 01E0800203, 01E0800410, 01K0700113, 01K0700198, 01K0700298, 01L0700009, 01M0700131, T1202225, T1202961, T1209529, T1211719, T1213975, T1220115, T1226528, T1228532, T1229942, T1233481, T1235583, T1236588, T1239523, T1242799, T1248517, T1249582, T1250496, T1252394, T1255378, T1256389, T1258311, T1261008, T1262892, T1264925, T1270366, T1272027, T1273754, T1275784, T1277275, and T1280263; Product Description: HEMOCLIPS SMALL 300/BOX, Product Code: 523135, Lot number: 01A0800221, 01B0800284, 01E0800020, 01E0800051, 01E0800205, 01K0700299, 01L0700097, 01M0700054, T1202223, T1207485, T1210251, T1218339, T1224895, T1229939, T1231420, T1235581, T1239179, T1241604, T1243428, T1247446, T1248346, T1256385, T1258309, T1260080, T1261781, T1270990, T1272023, and T1276617; Product Description: HEMOCLIP MED-LGE 200/BOX, Product Code: 523160, Lot number: 01K0700199, 01L0700098, T1201401, T1202195, T1210839, T1213979, T1229935, T1237417, T1240028, T1242797, T1260076, and T1271937; Product Description: HEMOCLIP LARGE 150/BOX, Product Code: 523170, Lot number: 01A0800325, 01D0800157, 01E0800018, 01L0700340, T1198153, T1201448, T1203611, T1210220, T1214463, T1218859, T1228527, T1237522, T1238441, T1242798, T1246173, T1248344, T1253536, T1254318, T1255373, T1258761, T1262886, T1264105, T1276611, and T1280177; Product Description: HEMOCLIP TEN PAK MEDIUM 200/BOX, Product Code: 523300, Lot number: 01B0800289, 01D0800158, 01F0800071, 01K0700200, 01K0700300, 01L0700010, 01M0700055, T1195698, T1203615, T1208575, T1213976, T1216526, T1227714, T1228534, T1231501, T1233521, T1234311, T1252395, T1254402, T1260323, T1262893, T1266943, T1270995 and T1276883; Product Description: HEMOCLIP TEN PAK SMALL 240/BOX, Product Code: 523335, Lot number: 01A0800327, 01C0800296, 01D0800159, T1203612, T1213977, T1221073, T1225877, T1230388, T1237120, T1239180, T1241605, T1251449, T1253540, T1260321, T1261792, T1273752, and T1277291; Product Description: HEMOCLIP TEN PAK MED-LG 160/BX, Product Code: 523360, Lot number: 01A0800328, 01C0800244, T1195769, T1196987, T1199780, T1208571, T1218337, T1229936, T1237418, T1247368, T1255369, T1264918, T1271938, and T1273748; Product Description: HEMOCLIP TEN PAK LG 120/BOX, Product Code: 523370, Lot number: 01C0800245, T1202199, T1209526, T1211715, T1227696, T1234309, T1238442, T1239176, T1243426, T1245243, T1248508, T1250484, T1254319, T1267799, T1268809, T1275639, T1276612, T1278104, and T1279053; Product Description: HEMOCLIP S/S MEDIUM 250/BOX, Product Code: 523400, Lot number: 01A0800329, 01D0800086, 01E0800409, T1226527, T1226762, T1229941, T1232352, T1237527, T1238445, T1248515, T1249520, T1250494, T1251452, T1261740, T1262890, T1264923, T1266142, T1270993, T1272025, T1275783, T1278107, and T1279058; Product Description: HEMOCLIP S/S SMALL 300/BOX, Product Code; 523435, Lot number: 01E0800144, 01L0700182, 01M0700132, T1200641, T1232348, T1239177, T1247445, T1255376, T1257214, T1262887, and T1276616; Product Description: HEMOCLIP S/S MED/LG 200/BOX, Product Code: 523460, Lot number: 01B0800076, 01D0800234, 01L0700258, T1201481, T1203609, T1206790, T1212659, T1219274, T1224891, T1234306, T1239175, T1245241, T1252391, T1255370, T1271939, and T1277285; Product Description: HEMOCLIP S/S LARGE 150/BOX, Product Code: 523470, Lot number: 01B0800163, 01C0800064, 01L0700171, 01M0700133, T1214678, T1226761, T1229937, T1237523, T1240293, T1255374, T1257213, T1260078, T1267800, T1276613, T1277287, and T1280178; Product Description: HEMOCLIP S/S MEDIUM 200/BOX, Product Code: 523600, Lot number: 01B0800389, 01D0800160, 01E0800021, 01L0700099, 01M0700134, T1211718, T1216521, T1227711, T1230389, T1238446, T1242668, T1247371, T1251453, T1256388, T1262891, T1264924, T1266942, T1270994, T1272879, T1277274, and T1280262; Product Description: HEMOCLIP S/S SMALL 240/BOX, Product Code: 523635, Lot number: 01A0800050, 01A0800169, 01C0800143, 01C0800246, 01C0800295, 01D0800236, T1201422, T1202222, T1206018, T1209527, T1211716, T1213978, T1221290, T1224894, T1227708, T1230387, T1233478, T1237119, T1239178, T1240295, T1253538, T1259106, T1262888, T1266119, T1268812, T1270989, T1273751, T1278105, and T1279054; Product Description: HEMOCLIP S/S MEDIUM-LARGE 160/BOX, Product Code: 523660, Lot number: 01A0800037, T1202196, T1256382, T1262885, and T1271940; Product Description: HEMOCLIP S/S LARGE 120/BOX, Product Code: 523670, Lot number: 01A0800051, 01C0800065, T1228528, T1237524, T1245245, T1248345, T1266118, and T1277288; Product Description: HEMOCLIP TITANIUM MEDIUM 250/BOX, Product Code: 523700, Lot number: 01A0800052, 01A0800170, 01A0800331, 01A0800426, 01A0800427, 01B0800390, 01D0800087, 01D0800088, 01D0800283, 01D0800325, 01E0800412, 01K0700286, 01L0700100, 01L0700342, T1202226, T1203616, T1214464, T1222328, T1223063, T1224897, T1226763, T1230390, T1231505, T1232353, T1233482, T1234312, T1235584, T1236584, T1238447, T1244668, T1248519, T1249585, T1252396, T1253543, T1255379, T1255380, T1257215, T1258314, T1259111, T1260324, T1261794, T1262894, T1264108, T1266144, T1266944, T1268384, T1270368, T1270996, T1272028, T1272029, T1273755, T1275785, and T1279059; Product Description: HEMOCLIP TITANIUM SMALL 300/BOX, Product Code: 523735, Lot number: 01B0800315, 01C0800145, 01C0800297, 01D0800395, 01E0800146, 01E0800204, T1192807, T1195697, T1202224, T1216520, T1221291, T1222327, T1223064, T1226526, T1228531, T1229940, T1232349, T1236587, T1237526, T1239521, T1241480, T1243837, T1245247, T1249518, T1251450, T1252393, T1253541, T1258215, T1259108, T1261004, T1262889, T1266941, T1268815, T1270364, T1270991, T1272877, T1273753, T1275781, T1276620, T1278106, and T1279056; Product Description: HEMOCLIP TITANIUM MEDIUM-LARGE 200/BOX, Product Code: 523760, Lot number: 01A0800222, 01B0800077, 01D0800008, 01D0800164, 01E0800143, T1202197, T1208572, T1210838, T1234307, T1237419, T1247369, T1252392, T1256383, T1257719, T1258560, T1259103, T1261790, T1266799, T1272021, T1273749, and T1277286; Product Description: HEMOCLIP TITANIUM LARGE 150/BOX, Product Code: 523770, Lot number: 01A0800054, 01D0800235, 01D0800322, 01L0700011, 01L0700260, T1202200, T1215225, T1220112, T1224663, T1227699, T1228529, T1237525, T1238443, T1244223, T1247370 , T1248510 , T1250486 , T1254320, T1259104, T1264919, T1272875, T1276614, and T1280179; Product Description: HEMOCLIP TITANIUM MEDIUM 200/BOX, Product Code: 523800, Lot number 1A0800223, 01A0800428, 01B0800165, 01C0800247, 01C0800299, 01D0800089, 01D0800288, 01D0800337, 01E0800023, 01K0700301, 01L0700012, 01L0700178, 01L0700261, 01L0700343, 01M0700136, T1192808, T1202227, T1206021, T1207491, T1213973, T1222336, T1223062, T1224085, T1226764, T1228535, T1229944, T1231510, T1232354, T1233483, T1234314, T1235585, T1238448, T1239525, T1241011, T1241602, T1242669, T1243437, T1244224, T1244667, T1247447, T1248348, T1249587, T1250498, T1252397, T1252398, T1253544, T1254404, T1256391, T1258216, T1259112, T1260326, T1260617, T1261795, T1261796 T1264109, T1264926, T1266145, T1266946, T1268385, T1270369, T1270997, T1272880, T1273756, T1275787, T1276885, T1278109, and T1279060; Product Description: HEMOCLIP TITANIUM SMALL 240/BOX, Product Code: 523835, Lot number: 01A0800171, 01A0800224, 01C0800146, 01C0800248, 01C0800298, 01D0800146, 01D0800161, 01D0800323, 01E0800290, 01F0800084, 01K0700114, 01K0700202, 01K0700302, 01L0700161, 01L0700262, 01L0700344, 01M0700137, T1195699, T1208574, T1213974, T1217528, T1224083, T1227710, T1232350, T1233479, T1235582, T1241601, T1246175, T1248347, T1249519, T1251451, T1256386, T1258310, T1260322, T1261006, T1264107, T1264922, T1266141, T1268381, T1268816, T1270365, T1270992, T1272878, T1275782, T1276881, and T1277293; Product Description: HEMOCLIP TITANIUM MEDIUM-LARGE 160/BOX, Product Code: 523860, Lot number: 01K0700203, 01L0700013, 01L0700183, 01M0700138, T1195700, T1201399, T1202198, T1202860, T1203610, T1206016, T1213980, T1218338, T1226600, T1227690, T1230384, T1234308, T1235439, T1237521, T1238396, T1240292, T1244666, T1245242, T1248343, T1253535 , T1255372, T1256384, T1260077, T1261791, T1262882, T1264104, T1266117, T1266800, T1272022, T1273750, T1278103, and T1279050; Product Description: HEMOCLIP TITANIUM LARGE 120/BOX, Product Code: 523870, Lot number: 01A0800055, 01B0800388, 01C0800294, 01D0800165, 01E0800019, 01E0800206, 01K0700303, 01L0700014, 01L0700184, T1192809, T1202221, T1212660, T1220113, T1225876, T1227701, T1230386, T1236585, T1238444, T1244676, T1246174, T1248512, T1253537, T1254401, T1255375, T1258762, T1260079, T1261782, T1264920, T1268810, T1272876, T1276615, and T1280180.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Dirección del fabricante
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA