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U.S. Department of Health and Human Services

Class 2 Device Recall Bard DuaLok Breast Lesion Localization Wire

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  Class 2 Device Recall Bard DuaLok Breast Lesion Localization Wire see related information
Date Initiated by Firm August 26, 2014
Date Posted September 16, 2014
Recall Status1 Terminated 3 on March 06, 2015
Recall Number Z-2648-2014
Recall Event ID 69136
510(K)Number K935457  
Product Classification Guide, needle, surgical - Product Code GDF
Product Bard DuaLok Breast Lesion Localization Wire,
Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm).

The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biopsies.
Code Information LW0037 REVH0625 LW0037 REVJ0285 LW0037 REVK0279 LW0037 REWD1346 LW0037 REWE1663 LW0037 REWH0210 LW0037 REWJ1662 LW0037 REWL1233 LW0037 REXC0151 LW0037 REXC1597 LW0037 REXJ0487 LW0037 REXK2010 LW0037 REYB1500 LW0037 REYC1644 LW0037 REYE2175 LW0037 REYG0975 LW0057 REVH1110 LW0057 REXF0126 LW0057 REVJ0284 LW0057 REXF2249 LW0057 REVJ1392 LW0057 REXG2346 LW0057 REVK0821 LW0057 REXH0014 LW0057 REWA0386 LW0057 REXH1180 LW0057 REWB0291 LW0057 REXJ0280 LW0057 REWB1686 LW0057 REXJ0560 LW0057 REWC0831 LW0057 REXJ2036 LW0057 REWD1328 LW0057 REXK0397 LW0057 REWE1476 LW0057 REXK0676 LW0057 REWF1566 LW0057 REXL0506 LW0057 REWG1788 LW0057 REYA0345 LW0057 REWG1807 LW0057 REYA1244 LW0057 REWJ1663 LW0057 REYA2521 LW0057 REWJ1664 LW0057 REYB1364 LW0057 REWK1459 LW0057 REYC0520 LW0057 REWL1432 LW0057 REYD1314 LW0057 REXB0180 LW0057 REYE2170 LW0057 REXC0152 LW0057 REYF0719 LW0057 REXC1592 LW0057 REYF1846 LW0077 REVJ0287 LW0077 REWI1706 LW0077 REXH1476 LW0077 REVJ1391 LW0077 REWJ1174 LW0077 REXH1519 LW0077 REVK0280 LW0077 REWJ1679 LW0077 REXI1623 LW0077 REVL0641 LW0077 REWK1425 LW0077 REXI1846 LW0077 REWA1600 LW0077 REWL0885 LW0077 REXJ2030 LW0077 REWB0099 LW0077 REWL1436 LW0077 REXK0937 LW0077 REWB1751 LW0077 REXA1813 LW0077 REYA0199 LW0077 REWC0848 LW0077 REXC0751 LW0077 REYA0346 LW0077 REWC1485 LW0077 REXC1113 LW0077 REYA2522 LW0077 REWD1230 LW0077 REXD1361 LW0077 REYB1366 LW0077 REWD1426 LW0077 REXD1362 LW0077 REYC0486 LW0077 REWE1052 LW0077 REXE1361 LW0077 REYC0648 LW0077 REWE1479 LW0077 REXF0129 LW0077 REYC2209 LW0077 REWF0904 LW0077 REXG0098 LW0077 REYD1387 LW0077 REWG1776 LW0077 REXG0602 LW0077 REYE2137 LW0077 REWH0282 LW0077 REXG1586 LW0077 REYF1017 LW0077 REWI0065 LW0077 REXG2360 LW0077 REYG1057 LW0107 REVH1111 LW0107 REWI1586 LW0107 REXJ0484 LW0107 REVJ0282 LW0107 REWI1746 LW0107 REXJ1985 LW0107 REVK0267 LW0107 REWJ1560 LW0107 REXJ2326 LW0107 REVK0284 LW0107 REWK0101 LW0107 REXK1320 LW0107 REVK0817 LW0107 REWK1426 LW0107 REXK2000 LW0107 REVL0570 LW0107 REWL1438 LW0107 REXL0556 LW0107 REWA0735 LW0107 REXA1919 LW0107 REXL0794 LW0107 REWB0295 LW0107 REXB0181 LW0107 REYA2523 LW0107 REWB1683 LW0107 REXB1602 LW0107 REYB0456 LW0107 REWC0818 LW0107 REXC0153 LW0107 REYB0950 LW0107 REWD1248 LW0107 REXC0990 LW0107 REYB2182 LW0107 REWD1471 LW0107 REXC1593 LW0107 REYC0484 LW0107 REWE1080 LW0107 REXD1822 LW0107 REYC1490 LW0107 REWE1483 LW0107 REXE1360 LW0107 REYC2848 LW0107 REWE1678 LW0107 REXE1822 LW0107 REYD1711 LW0107 REWF0895 LW0107 REXF1309 LW0107 REYE0543 LW0107 REWF1677 LW0107 REXF2250 LW0107 REYE1146 LW0107 REWG0934 LW0107 REXG1585 LW0107 REYE2177 LW0107 REWH0182 LW0107 REXG2347 LW0107 REYF0183 LW0107 REWH0231 LW0107 REXH2398 LW0107 REYG0968 LW0107 REWI0053 LW0107 REXH2399 LW0107 REYG1607 LW0107 REWI0097 LW0107 REXI1196 LW0107 REWI0997 LW0107 REXI1807 LW0137 REVH0330 LW0137 REXD1069 LW0137 REVJ0283 LW0137 REXG0099 LW0137 REVK0266 LW0137 REXG2348 LW0137 REVK0841 LW0137 REXH1956 LW0137 REWB1757 LW0137 REXI1193 LW0137 REWC1479 LW0137 REXJ0486 LW0137 REWD1331 LW0137 REXJ2029 LW0137 REWE1452 LW0137 REXK0402 LW0137 REWF1572 LW0137 REXK1345 LW0137 REWG1621 LW0137 REXL0507 LW0137 REWI0521 LW0137 REYA1245 LW0137 REWI1707 LW0137 REYB0486 LW0137 REWJ1672 LW0137 REYC1961 LW0137 REWK1449 LW0137 REYE1382 LW0137 REXB0182 LW0137 REYF0642 LW0137 REXB1527 LW0137 REYG1464 LW0137 REXC0154
Recalling Firm/
Bard Peripheral Vascular Inc
1625 W 3rd St Ste 109
Tempe AZ 85281-2438
For Additional Information Contact
Manufacturer Reason
for Recall
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier.
FDA Determined
Cause 2
Action A customer notification letter was sent on 8/27/14 to all customers who purchased the Bard DuaLok Breast Lesion Localization Wire. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to call Bard Peripheral's Recall Coordinator at (800) 321-4254 option#2 Ex 2727. Customers are instructed to fax the completed recall and effectiveness check form to BPV at (800) 994-6772.
Quantity in Commerce 177,760 units
Distribution Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.
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 = GDF and Original Applicant = BIP USA, INC.