ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
FDA device recall Z-1160-06 · posted 2006-06-22 · Terminated
Recall details
- Recalling firm
- Suros Surgical Systems Inc.
- Reason for recall
- Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging).
- Action taken
- Consignees were notified telephone and letter dated 5/25/06 to stop using the recalled product and to return it to the firm. The recall was extended to an additional lot by phone calls to each customer between Julne 26 and 30, 2006 and by letter dated 6/19/06 and sent between June 28 and July 7, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 939
- Distribution
- Nationwide.
- Date initiated
- 2006-05-25
- Date posted
- 2006-06-22
- Date terminated
- 2007-03-12
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACUUM ASSISTED CORE BIOPSY DEVICE (K010400) | Promex, Inc. | 2001-07-24 |