ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
FDA device recall Z-1061-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Sterility of the device may be compromised due to a lack of package integrity
- Action taken
- Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 1,030 units
- Distribution
- Nationwide
- Date initiated
- 2003-07-03
- Date posted
- 2003-07-29
- Date terminated
- 2004-06-17
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE (K935814) | Boston Scientific Corp | 1994-03-14 |