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-0157-2009
  • 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=73453
  • 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; HEMO PLUS TITANIUM MEDIUM 25CLIP/10CART, Product Code: 533700, Lot number: 01B0800080, 01C0800069, 01E0800024, 01K0700109, 01K0700306, 01L0700104, 01M0700058, T1195792, T1202229, T1202963, T1206022, T1206785, T1210254, T1214002, T1224089, T1228537, T1232357, T1234317, T1240300, T1247376, and T1254408; Product Description: HEMO PLUS TI 25/CART 250BOX NO TAPE, Product Code: 533702, Lot number: 01B0800290, 01E0800025, 01E0800293, 01M0700139, T1199967, T1203683, T1221295, T1225871, T1232358, T1234318, T1251457, T1257218, T1258316, T1259116, T1268818, T1270999, T1278115, and T1279064; Product Description: HEMO PLUS TITANIUM SMALL 25CLIP/12CART, Product Code: 533735, Lot number: 01A0800010, 01C0800109, T1201389, T1206042, T1206786, T1207492, T1208578, T1214465, T1224086, T1228536, T1231515, T1234316, T1238449, T1239526, T1246179, T1250500 T1254405, T1262895, and T1272030; Product Description: HEMO PLUS TI 25/CART 300BOX NO TAPE, Product Code: 533737, Lot number: 01E0800055, 01E0800056, 01M0700059, T1192804, T1194951, T1196289, T1202185, T1203619, T1210837, T1214003, T1215227, T1217531, T1221292, T1225870, T1229945, T1232356, T1233484, T1235586, T1240297, T1247375, T1251454, T1257216, T1260327, T1266947, T1268387, and T1278110; Product Description: HEMO PLUS TITANIUM MEDIUM 10 CLIP/18CART, Product Code: 533800, Lot number: 01A0800013, 01A0800185, 01A0800186, 01A0800229, 01A0800230, 01A0800314, 01A0800336, 01A0800392, 01A0800433, 01D0800084, 01D0800328, 01E0800149, 01F0800074, 01K0700003, 01K0700116, 01K0700204, 01L0700018, 01L0700188, 01L0700265, 01M0700060, T1201390, T1203684, T1208580, T1212802, T1217533, T1218343, T1221294, T1222331, T1222960, T1224090, T1224964, T1226766, T1232359, T1233485, T1234319, T1235590, T1236583, T1240321, T1242824, T1243562, T1244226, T1245248, T1246361, T1247377, T1252441, T1252442, T1254409, T1256392, T1257219, T1258317, T1259117, T1260329, T1261011, T1262820, T1264112, T1264113, T1264928, T1266149, T1268391, T1268819, T1275790, T1276887, T1277326, T1278116, and T1280265; Product Description: HEMO PLUS TI M10/18CART NO TAPE, Product Code: 533802, Lot number: 01A0800187, 01A0800337, 01B0800081, 01B0800291, 01D0800009, 01K0700004, T1195762, T1198822, T1205309, T1209534, T1225872, T1229947, T1237528, T1239527, T1242825, T1246362, T1255383, T1257220, T1259118, T1260330, T1264114, T1268392, T1268820, T1271000, T1273222, T1275791, T1278117, and T1279066; Product Description: HEMO PLUS TITANIUM SMALL 10 CLIP/18 CART, Product Code: 533835, Lot number: 01A0800011, 01A0800059, 01D0800081, 01D0800082, 01D0800326, 01E0800148, 01K0700205, 01K0700307, 01L0700105, 01L0700349, 01M0700140, T1195763, T1202228, T1203681, T1205302, T1208579, T1218922, T1222329, T1222959, T1224962, T1236590, T1238450, T1241603, T1244677, T1246180, T1249588, T1250501, T1251455, T1254407, T1259115, T1261009, T1262896, T1264110, T1266147, T1266948, T1268388, T1268817, T1275788, T1276886, and T1277323; Product Description: HEMO PLUS TI S10/18CART NO TAPE, Product Code: 533837, Lot number: 01A0800060, 01A0800338, 01D0800083, 01D0800327, 01K0700117, 01L0700106, T1192805, T1196288, T1202962, T1209531, T1224087, T1227715, T1230391, T1235587, T1242821, T1243440, T1244225, T1247503, T1251456, T1261797, T1264111, T1270370, T1273757, and T1280264; Product Description: HEMO PLUS TITANIUM MED-LGE 10CLIP/12CART, Product Code: 533860, Lot number: 01A0800101, 01A0800174, 01A0800339, 01B0800169, 01D0800085, 01E0800199, 01F0800075, 01K0700308, 01L0700019, 01L0700266, 01M0700061, T1201391, T1208601, T1215228, T1219118, T1220119, T1222330, T1223061, T1224966, T1225873, T1233486, T1234320, T1236337, T1245249, T1249589, T1251458, T1252443, T1264929, T1266949, T1269021, T1276888, and T1277328; Product Description: HEMO PLUS TI ML10/12CART NO TAPE, Product Code: 533862, Lot number: 01A0800340, T1195764, T1205306, T1225874, T1227718, T1231520, T1233487, T1242826, T1246363, T1248465, T1250503, T1251459, T1257301, T1261012, T1266950, T1271001, and T1280266; Product Description: HEMO PLUS TITANIUM LARGE 10CLIP/12CART, Product Code: 533870, Lot number: 01A0800231, 01D0800295, 01F0800014, 01F0800076, 01L0700020, 01L0700189, 01M0700141, T1199779, T1203685, T1206784, T1210835, T1211782, T1216524, and T1221072; Product Description: HEMO PLUS TI L10/12CART NO TAPE, Product Code: 533872, Lot number: 01B0800393, 01F0800077, 01L0700267, T1199778, T1220120, T1234381, T1244678, T1252444, T1254410, and T1270372; Product Description: HEMO PLUS STRGPT TI SM25/CART, Product Code: 534735, 300/BX, Lot number: 01C0800067, T1196287, T1199966, T1205303, T1218342, T1220117, T1230392, T1238451, T1242822, T1273221, T1278111, and T1279061; Product Description: HEMO PLUS STRONGPOINT SM NOTAPE 300 25, Product Code: 534737, Lot number: 01D0800162, T1201388, T1209532, T1210253, T1217532, T1224088, T1227717, T1235588, T1240298, T1260328, T1268389, T1278112, and T1279062; Product Description: HEMO PLUS STRGPT TI SM10/CART 180BX, Product Code: 534835, Lot number: 01A0800012, 01A0800434, 01B0800392, 01E0800292, 01E0800415, 01K0700206, 01M0700062, T1195765, T1203682, T1205304, T1209533, T1221293, T1225308, T1226765, T1229946, T1231519, T1238452, T1240299, T1242823, T1250502, T1252400, T1257217, T1258315, T1264927, T1268390, T1275789, T1277325, and T1278113; Product Description: HEMO PLUS STRONGPOINT SM NO TAPE 180 10, Product Code: 534837, Lot number: T1220118, T1235589, T1261010, T1266148, T1278114, and T1279063.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    Weck Hemoclip Plus¿ 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