Class 2 Device Recall Weck

• Date Initiated by Firm: August 22, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on March 15, 2012
• Recall Number: Z-0159-2009
• Recall Event ID: 49452
• 510(K)Number: K021808
• Product Classification: Implantable clip - Product Code FZP
• 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 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 Information: 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
• Recalling Firm/ Manufacturer: Telefelx Medical; 2917 Weck Drive; Durham NC 27709
• Manufacturer Reason for Recall: A hole in the sterile unit blister pack was detected that would compromise sterility.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FZP