Telefelx Medical WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. 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 int Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. 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 int
Brand
Telefelx Medical
Lot Codes / Batch Numbers
Product manufactured from January 2006 through July 2008, (Product Description: HOL SMALL CLIPS 1 PACK, Product Code: 544210, Lot number: 01C0800150, and T1278089, Product Description: HOL SMALL CLIPS 4 PACK, Product Code: 544214, Lot number: T1278090, and T1278091, Product Description: HOL SMX CLIPS, Product Code: 544220, Lot number: 01D0800096, 01D0800274, 01M0700186, T1199965, T1203687, T1217534, T1228540, T1238491, T1240322, T1250508, T1254468, T1260331, T1261800, T1264120, T1264930, T1266953, T1271002, T1275103, and T1279909, Product Description: HOL ML CLIPS, Product Code: 544230, Lot number: 01A0800008, 01A0800061, 01A0800062, 01A0800177, 01A0800233, 01A0800344, 01A0800435, 01B0800174, 01B0800293, 01B0800374, 01C0800060, 01C0800149, 01C0800302, 01D0800094, 01D0800136, 01D0800275, 01E0800079, 01E0800112, 01E0800159, 01E0800249, 01E0800334, 01F0800022, 01F0800117, 01K0700006, 01K0700119, 01M0700014, 01M0700147, T1202230, T1202965, T1203688, T1213241, T1214808, T1218508, T1220366, T1222324, T1225867, T1226767, T1228410, T1228561, T1229915, T1230518, T1231590, T1232367, T1233411, T1234215, T1235422, T1237016, T1238490, T1239528, T1244679, T1246346, T1246459, T1247429, T1249597, T1252218, T1252509, T1253546, T1254469, T1256202, T1256393, T1257303, T1258318, T1259122, T1261014, T1261801, T1262898, T1264221, T1264931, T1266150, T1266151, T1266954, T1268393, T1272013, T1272014, T1273718, T1276889, T1276890, T1277330, T1278118, T1279067, and T1279910, Product Description: HOL L CLIPS, Product Code: 544240, Lot number: 01A0800007, 01A0800094, 01A0800139, 01A0800188, 01A0800234, 01A0800318, 01A0800382, 01A0800383, 01B0800040, 01B0800047, 01B0800048, 01B0800116, 01B0800130, 01B0800205, 01B0800206, 01B0800331, 01C0800007, 01C0800008, 01C0800076, 01C0800107, 01C0800184, 01C0800254, 01D0800001, 01D0800002, 01D0800111, 01D0800198, 01D0800199, 01D0800277, 01D0800329, 01E0800009, 01E0800057, 01E0800058, 01E0800160, 01E0800161, 01E0800250, 01E0800251, 01E0800296, 01E0800353, 01E0800416, 01E0800417, 01F0800037, 01K0700008, 01K0700120, 01K0700272, 01L0700021, 01L0700107, 01L0700190, 01L0700271, 01M0700098, 01M0700126, and 01M0700148, Product Description: HOL XL CLIPS (EXTRA LARGE), Product Code: 544250, Lot number: 01A0800436, 01B0800082, 01B0800175, 01B0800294, 01B0800375, 01C0800255, 01C0800304, 01D0800141, 01E0800252, 01E0800352, 01K0700209, 01K0700310, 01L0700022, 01L0700191, 01L0700268, T1195768, T1202966, T1203690, T1208603, T1210246, T1211617, T1216058, T1221102, T1223849, T1226768, T1227722, T1228562, T1229917, T1230520, T1231592, T1232369, T1233413, T1234217, T1235424, T1236592, T1237531, T1238493, T1240323, T1244680, T1246541, T1247431, T1249598, T1250510, T1251534, T1252511, T1253547, T1256395, T1257305, T1258320, T1259124, T1261803, T1262822, T1262900, T1266956, T1268394, T1269024, T1270229, T1271005, T1273225, T1273797, T1275793, T1276892, T1277331, T1278121, and T1279068
Products Sold
Product manufactured from January 2006 through July 2008; (Product Description: HOL SMALL CLIPS 1 PACK, Product Code: 544210, Lot number: 01C0800150, and T1278089; Product Description: HOL SMALL CLIPS 4 PACK, Product Code: 544214, Lot number: T1278090, and T1278091; Product Description: HOL SMX CLIPS, Product Code: 544220, Lot number: 01D0800096, 01D0800274, 01M0700186, T1199965, T1203687, T1217534, T1228540, T1238491, T1240322, T1250508, T1254468, T1260331, T1261800, T1264120, T1264930, T1266953, T1271002, T1275103, and T1279909; Product Description: HOL ML CLIPS, Product Code: 544230, Lot number: 01A0800008, 01A0800061, 01A0800062, 01A0800177, 01A0800233, 01A0800344, 01A0800435, 01B0800174, 01B0800293, 01B0800374, 01C0800060, 01C0800149, 01C0800302, 01D0800094, 01D0800136, 01D0800275, 01E0800079, 01E0800112, 01E0800159, 01E0800249, 01E0800334, 01F0800022, 01F0800117, 01K0700006, 01K0700119, 01M0700014, 01M0700147, T1202230, T1202965, T1203688, T1213241, T1214808, T1218508, T1220366, T1222324, T1225867, T1226767, T1228410, T1228561, T1229915, T1230518, T1231590, T1232367, T1233411 , T1234215, T1235422, T1237016, T1238490, T1239528, T1244679, T1246346, T1246459, T1247429, T1249597, T1252218, T1252509, T1253546, T1254469, T1256202, T1256393, T1257303, T1258318, T1259122, T1261014, T1261801, T1262898, T1264221, T1264931, T1266150, T1266151, T1266954, T1268393, T1272013, T1272014, T1273718, T1276889, T1276890, T1277330, T1278118, T1279067, and T1279910; Product Description: HOL L CLIPS, Product Code: 544240, Lot number: 01A0800007, 01A0800094, 01A0800139, 01A0800188, 01A0800234, 01A0800318, 01A0800382, 01A0800383, 01B0800040, 01B0800047, 01B0800048, 01B0800116, 01B0800130, 01B0800205, 01B0800206, 01B0800331, 01C0800007, 01C0800008, 01C0800076, 01C0800107, 01C0800184, 01C0800254, 01D0800001, 01D0800002, 01D0800111, 01D0800198, 01D0800199, 01D0800277, 01D0800329, 01E0800009, 01E0800057, 01E0800058, 01E0800160, 01E0800161, 01E0800250, 01E0800251, 01E0800296, 01E0800353, 01E0800416, 01E0800417, 01F0800037, 01K0700008, 01K0700120, 01K0700272, 01L0700021, 01L0700107, 01L0700190, 01L0700271, 01M0700098, 01M0700126, and 01M0700148; Product Description: HOL XL CLIPS (EXTRA LARGE), Product Code: 544250, Lot number: 01A0800436, 01B0800082, 01B0800175, 01B0800294, 01B0800375, 01C0800255, 01C0800304, 01D0800141, 01E0800252, 01E0800352, 01K0700209, 01K0700310, 01L0700022, 01L0700191, 01L0700268, T1195768, T1202966, T1203690, T1208603, T1210246, T1211617, T1216058, T1221102, T1223849, T1226768, T1227722, T1228562, T1229917, T1230520, T1231592, T1232369, T1233413, T1234217, T1235424, T1236592, T1237531, T1238493, T1240323, T1244680, T1246541, T1247431, T1249598, T1250510, T1251534, T1252511, T1253547, T1256395, T1257305, T1258320, T1259124, T1261803, T1262822, T1262900, T1266956, T1268394, T1269024, T1270229, T1271005, T1273225, T1273797, T1275793, T1276892, T1277331, T1278121, and T1279068
Telefelx Medical is recalling WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27 due to A hole in the sterile unit blister pack was detected that would compromise sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A hole in the sterile unit blister pack was detected that would compromise sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026