Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, I
FDA device recall Z-0715-06 · posted 2006-04-11 · Terminated
Recall details
- Recalling firm
- Rubicor Medical
- Reason for recall
- Devices' sterility may be compromised due to lack of adequate sterilization.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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
- Date initiated
- 2006-02-17
- Date posted
- 2006-04-11
- Date terminated
- 2006-05-11
- Location
- Redwood City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 (K052506) | Rubicor Medical, Inc. | 2005-10-06 |
| RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 (K032584) | Rubicor Medical, Inc. | 2003-09-17 |
| MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 (K030049) | Rubicor Medical, Inc. | 2003-01-29 |
| RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 (K023601) | Rubicor Medical, Inc. | 2002-11-19 |
| RUBICOR BREAST BIOPSY DEVICE (K020047) | Rubicor Medical, Inc. | 2002-04-05 |