Recall Z-2648-2014 ยท GDF Guide, Needle, Surgical
Bard Peripheral Vascular Inc
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.
| Date | Sep 16, 2014 (initiated Aug 26, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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 | 177,760 units |
| Distribution | Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935457 | LOCALIZATION WIRE OR MARKER - SURGICAL Bip USA, Inc., Feb 17, 1994 |