Recall Z-0715-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rubicor Medical
Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
| Date | Apr 11, 2006 (initiated Feb 17, 2006) |
| Status | Terminated |
| Reason | Devices' sterility may be compromised due to lack of adequate sterilization. |
| Root cause | Other |
| Action | On 2/17/06, the firm initiated the recall and its notification was via sales rep retrieval and follow-up letter dated 3/13/06 explaining the reason for the recall and requesting the product be returned. |
| Quantity | 19 units |
| Distribution | Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to retrieve 18 units, only one (1) was used by a consignee. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, physicians |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020047 | RUBICOR BREAST BIOPSY DEVICE Rubicor Medical, Inc., Apr 5, 2002 |
| K023601 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 Rubicor Medical, Inc., Nov 19, 2002 |
| K030049 | MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 Rubicor Medical, Inc., Jan 29, 2003 |
| K032584 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 Rubicor Medical, Inc., Sep 17, 2003 |
| K052506 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 Rubicor Medical, Inc., Oct 6, 2005 |