Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(
FDA device recall Z-2648-2014 · posted 2014-09-16 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDF
- Quantity affected
- 177,760 units
- Distribution
- Worldwide Distribution-USA (nationwide), Australia, Canada, and European, Latin American and Asian Pacific countries.
- Date initiated
- 2014-08-26
- Date posted
- 2014-09-16
- Date terminated
- 2015-03-06
- Location
- Tempe, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LOCALIZATION WIRE OR MARKER - SURGICAL (K935457) | Bip USA, Inc. | 1994-02-17 |