Events

Recall of Device Recall Weck

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Telefelx Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49452
  • Event Risk Class
    Class 2
  • Event Number
    Z-0159-2009
  • Event Initiated Date
    2008-08-22
  • Event Date Posted
    2008-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73455
  • Notes / Alerts
    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.
  • Extra notes in the data
    Implantable clip - Product Code FZP
  • Reason
    A hole in the sterile unit blister pack was detected that would compromise sterility.
  • 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.

Device

Device Recall Weck
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    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.
  • Manufacturer
    Telefelx Medical

Manufacturer

Telefelx Medical
  • Manufacturer Address
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA