Z-0158-2009

Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the...

Name: Z-0158-2009 Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the...
Creator: Telefelx Medical
Published: 2008-08-22
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2008-08-22 / Terminated / root cause: packaging

FDA source

Telefelx Medical began a recall of Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the reusable Teleflex Medical metal ligating clips is... on 2008-08-22. The reason FDA records is "A hole in the sterile unit blister pack was detected that would compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0158-2009
Status: Terminated
Initiated: 2008-08-22
Posted: 2008-09-16
Terminated: 2012-03-15
Recalling firm: Teleflex Medical
Product: 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.
Product code: FZP Clip, Implantable
Reason for recall: A hole in the sterile unit blister pack was detected that would compromise sterility.
Root cause tag: packaging
FDA root cause: 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.
Quantity in commerce: 786036 (total pieces)
Distribution: Nationwide
Product codes and lots: 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 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.

Product code FZP

K021808Class IIWeck Hem-O-Lok Automatic Ligating Clip ApplierWeck / cleared 2002-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)