The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Bi
FDA device recall Z-0518-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- USA Instruments Incorporated
- Reason for recall
- The packaging used for the Breast Biopsy plate may exhibit small holes or tears
- Action taken
- The recalling firm notified consignees via certified letter, dated 1/31/07.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- Approximately 2200 units for all products being recalled
- Distribution
- Worldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Irel
- Date initiated
- 2007-01-31
- Date posted
- 2007-02-15
- Date terminated
- 2012-04-13
- Location
- Aurora, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3T HD BREAST ARRAY (K052585) | Usa Instruments, Inc. | 2005-10-04 |
| LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K041695) | Usa Instruments, Inc. | 2004-07-23 |