Terminated

Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063

FDA Recall Z-0715-06 · Posted 2006-04-11

Recalling FirmRubicor Medical

Recall StatusTerminated

Product CodeGEI

Date Initiated2006-02-17

Date Terminated2006-05-11

Product Quantity19 units

Reason for Recall

Devices' sterility may be compromised due to lack of adequate sterilization.

Firm 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.

Root Cause

Other

Distribution Pattern

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 who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052506RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108Rubicor Medical, Inc. · 2005-10-06 K032584RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629Rubicor Medical, Inc. · 2003-09-17 K030049MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086Rubicor Medical, Inc. · 2003-01-29 K023601RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086Rubicor Medical, Inc. · 2002-11-19 K020047RUBICOR BREAST BIOPSY DEVICERubicor Medical, Inc. · 2002-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.