FDA
Rubicor EnCapsule Breast Biopsy Device, Part Number 31358,
Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
Devices' sterility may be compromised due to lack of adequate sterilization.
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.