Recall Z-1061-03 ยท KNW Instrument, Biopsy
Boston Scientific Corporation
ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
| Date | Jul 29, 2003 (initiated Jul 3, 2003) |
| Status | Terminated |
| Reason | Sterility of the device may be compromised due to a lack of package integrity |
| Root cause | Other |
| Action | 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. |
| Quantity | 1,030 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935814 | MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE Boston Scientific Corp, Mar 14, 1994 |