{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73454", "product_res_number": "Z-0158-2009", "event_date_initiated": "2008-08-22", "event_date_posted": "2008-09-16", "recall_status": "Terminated", "event_date_terminated": "2012-03-15", "res_event_number": "49452", "product_code": "FZP", "k_numbers": [ "K021808" ], "product_description": "Weck , Horizon Titanium 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.", "code_info": "Product manufactured from January 2006 through July 2008; Product Description: HORIZON SMALL TI 6 CLIP, Product Code, 001200, Lot Number: 01A0800045, 01A0800319, 01A0800417, 01B0800210, 01B0800307, 01B0800318, 01B0800381, 01C0800054, 01C0800235, 01C0800308, 01D0800032, 01D0800149, 01D0800263, 01E0800030, 01E0800138, 01E0800139, 01K0700193, 01K0700292, 01L0700001, 01L0700089, 01L0700179, 01L0700250, 01L0700332, 01M0700045, 01M0700124, T1196255, T1201496, T1202233, T1202969, T1211681, T1212807, T1214012, T1214145, T1214803, T1215232, T1216179, T1217538, T1219268, T1219949, T1221287, T1222337, T1222951, T1223070, T1223894, T1224976, T1225863, T1226772, T1227726, T1229961, T1233420, T1234210, T1240153, T1240325, T1242673, T1243571, T1244228, T1244723, T1245254, T1246551, T1250514, T1251540, T1252517, T1253551, T1254473, T1266156, T1266961, T1269027, T1272020, T1275128, T1275797, T1277337, T1278125, and T1279073. Product Description: HORIZON SMALL RED TI 6 CLIP WIDE SLOT, Product Code: 001201, Lot Number: 01A0800043, 01A0800165, 01A0800217, 01A0800311, 01A0800418, 01A0890013, 01B0800068, 01B0800151, 01B0800159, 01B0800247, 01C0800055, 01C0800151, 01C0800236, 01C0800309, 01D0800106, 01D0800150, 01D0800264, 01E0800031, 01K0700110, 01K0700194, 01K0700195, 01K0700293, 01L0700002, 01L0700090, 01L0700180, 01L0700251, 01L0700333, 01M0700046, 01M0700125, T1202970, T1203693, T1209125, T1209540, T1210249, T1211682, T1212302, T1212808, T1214013, T1214804, T1215233, T1216180, T1217539, T1218205, T1219269, T1219948, T1221078, T1221286, T1222338, T1222339, T1223892, T1224977, T1225864, T1226773, T1227727, T1228570, T1228610, T1229962, T1230586, T1231598, T1232375, T1233421, T1234211, T1234998, T1236595, T1238043, T1238498, T1239532, T1244229, T1244724, T1245255, T1246344, T1247434, T1248472, T1250515, T1251359, T1252518, T1253552, T1254474, T1255175, T1255389, T1256398, T1256399, T1257313, T1257314, T1258302, T1258344, T1259129, T1259130, T1260339, T1260340, T1261021, T1261809, T1263003, T1264939, T1266157, T1266158, T1266959, T1266960, T1268397, T1268398, T1268855, T1269028, T1269784, T1272061, T1272062, T1273232\n\n T1273235, T1275142, T1275146, T1275798, T1276895, T1277338, T1278126, T1278127, T1279074, and T1279915. Product Description: HORIZON MED TI CLIP, Product Code: 002200, Lot number: 01A0800047, 01A0800093, 01A0800167, 01A0800215, 01A0800276, 01A0800277, 01A0800313, 01A0800421, 01B0800071, 01B0800161, 01B0800296, 01B0800382, 01C0800056, 01C0800139, 01C0800239, 01C0800310, 01D0800023, 01D0800112, 01D0800233, 01E0800080, 01E0800140, 01E0800302, 01F0800081, 01F0800379, 01L0700004, 01L0700173, 01L0700181, 01L0700252, 01L0700334, 01M0700222, T1205292, T1206699, T1207473, T1208607, T1209126, T1209541, T1210250, T1211683, T1212809, T1213972, T1214009, T1214809, T1215180, T1216202, T1217540, T1219270, T1219944, T1220367, T1221276, T1222225, T1222801, T1223071, T1223895, T1224978, T1225865, T1226774, T1227728, T1228611, T1229615, T1230587, T1230588, T1231599, T1232376, T1233422, T1234212, T1234999, T1236596, T1238499, T1239533, T1241009, T1241609, T1243104, T1243105, T1243572, T1244230, T1244511, T1244725, T1246548, T1247435, T1248473, T1249599, T1250516, T1251541, T1252519, T1253553, T1256400, T1256401, T1257315, T1258345, T1259832, T1260421, T1261022, T1261810, T1264227, T1264826, T1264940, T1266341, T1266343, T1268399, T1269029, T1269030, T1270230, T1270231, T1271007, T1271008, T1272063, T1272064, T1273237, T1275155, T1275799, T1277428, T1277429, T1278128, T1279075, and T1279916. Product Description: HORIZON MED/LRG TI 6 CLIP, Produce Code: 003200, Lot number: 01A0800048, 01A0800194, 01A0800346, 01A0890012, 01B0800073, 01B0800162, 01B0800248, 01B0800297, 01B0800383, 01C0800057, 01C0800241, 01C0800311, 01D0800033, 01D0800154, 01D0800280, 01D0800335, 01D0800369, 01E0800141, 01E0800422, 01F0800036, 01F0800082, 01F0800169, 01K0700296, 01L0700006, 01L0700094, 01L0700174, 01L0700254, 01L0700330, 01L0700335, 01M0700049, 01M0700122, 01M0700123, T1196254, T1201499, T1202234, T1202235, T1202971, T1203694, T1206023, T1206700, T1207474, T1208563, T1209378, T1214014, T1214468, T1216782, T1218206, T1219271, T1219945, T1220365, T1221272, T1222958, T1223896, T1224979, T1226775, T1228342, T1229963, T1230589, T1231600, T1232377, T1233424, T1234213, T1235000, T1236554, T1236935, T1238503, T1239534, T1240141, T1241017, T1243128, T1244670, T1245256, T1246549, T1247342, T1247436, T1251542, T1252520, T1253554, T1254475, T1256402, T1257316, T1258346, T1259131, T1260422, T1261023, T1261811, T1263004, T1264228, T1264941, T1266344, T1266962, T1268400, T1269031, T1270232, T1271009, T1271010, T1272065, T1272066, T1273239, T1275168, T1275800, T1276896, T1277339, T1278129, T1279076, and T1279917. Product Description: HORIZON LARGE TI 6 CLIP, Product Code: 004200, Lot number: 01A0800014, 01A0800136, 01A0800220, 01A0800322, 01A0800424, 01B0800074, 01B0800384, 01C0800058, 01C0800242, 01D0800034, 01D0800155, 01E0800192, 01E0800304, 01E0800423, 01K0700009, 01K0700112, 01K0700297, 01L0700095, 01L0700175, 01L0700255, 01L0700337, 01M0700190, T1196253, T1206015, T1206781, T1207475, T1208564, T1209377, T1210120, T1210813, T1212330, T1214015, T1217541, T1219273, T1221273, T1223072, T1223897, T1225866, T1227729, T1228612, T1230590, T1231601, T1232378, T1233428, T1234214, T1235421, T1236194, T1237537, T1238505, T1239535, T1243129, T1245257, T1246550, T1247397, T1248462, T1249600, T1251220, T1252521, T1253555, T1254476, T1255390, T1256403, T1257318, T1257328, T1258347, T1259132, T1260423, T1261024, T1261812, T1262821, T1264229, T1264942, T1266346, T1266963, T1273809, T1275119, T1275430, T1275841, T1276897, T1277340, T1279077, and T1279918. Product Description: HORIZON MICRO TI 6 CLIP/CART 30 CART/BX, Product Code; 005200, Lot number: 01A0800044, 01B0800305, 01B0800385, 01D0800035, 01E0800193, 01E0800214, 01F0800083, 01L0700256, 01L0700338, 01M0700051, T1199816, T1203695, T1208608, T1212811, T1214016, T1219272, T1221288, T1227730, T1228613, T1238191, T1244726, T1247398, T1251543, T1253556, T1257319, T1262053, T1263005, T1275842, and T1278131.", "firm_fei_number": "3005747797", "recalling_firm": "Telefelx Medical", "address_1": "2917 Weck Drive", "city": "Durham", "state": "NC", "postal_code": "27709", "reason_for_recall": "A hole in the sterile unit blister pack was detected that would compromise sterility.", "root_cause_description": "Packaging process control", "action": "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.", "product_quantity": "786036 (total pieces)", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K032238", "K150840", "K021407", "K993424", "K841549", "K053252", "K040821", "K030311", "K071406", "K873309", "K232313", "K933887", "K143598", "K081031", "K091060", "K050344", "K151943", "K964470", "K982944", "K132658", "K020879", "K142777", "K030926", "K073123", "K033024", "K800079", "K851251", "K250643", "K173031", "K131107", "K140932", "K841548", "K032217", "K121194", "K220006", "K962043", "K020470", "K181488", "K091017", "K013264", "K032980", "K242541", "K152081", "K862404", "K945231", "K962016", "K200166", "K011402", "K230966", "K934087", "K964109", "K230480", "K915151", "K021808", "K142869", "K110699", "K864102", "K221495", "K900122", "K080753", "K950540", "K091987", "K011236", "K062057", "K902108", "K111930", "K012317", "K953908", "K771112", "K843589", "K820999", "K061288", "K944552", "K834267", 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"K202994", "K253903", "K143644", "K163261", "K090872", "K161758", "K850273", "K861471", "K953258", "K232970", "K063644", "K180650" ], "registration_number": [ "1020279", "3015453963", "3007829657", "2210968", "3045042524", "2029275", "3011430871", "1416980", "3026616094", "1417592", "3015183635", "3014479313", "3035387162", "9610612", "3008989837", "1047843", "2027111", "3015542154", "3009763019", "1825034", "3016678045", "3013184361", "3017196117", "3005160949", "3004215117", "3010383847", "3005636544", "2647580", "3011706110", "3008843439", "9612501", "3021194552", "3018094310", "1220948", "3003898360", "3011989923", "3004111573", "3004365956", "3017102971", "3014461810", "3007185216", "3005075853", "1527736", "9616088", "3014620201", "2024024", "3009609358", "1018470", "3010041511", "3008492462", "3008992312", "3017636737", "1219930", "2132556", "3030733800", "3015185328", "3009051888", "3008729892", "3012494290", "3017210488", "3008236846", "3038503932", "3021632375", "1422634", 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"3013176080", "3035366890", "2916714", "3004060107", "3009380063", "3002807555", "3015207155", "3016248634", "3014279513", "3010605922" ], "device_name": "Clip, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }