Recall Z-1160-06 ยท KNW Instrument, Biopsy
Suros Surgical Systems Inc.
ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09.
| Date | Jun 22, 2006 (initiated May 25, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging). |
| Root cause | Other |
| Action | 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. |
| Quantity | 939 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE Promex, Inc., Jul 24, 2001 |