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New Search Back To Search Results   Medical Device Recalls Class 2 Recall Rubicor Date Recall Initiated February 17, 2006 Date Posted April 11, 2006 Recall Number Z-0715-06 Product Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063 Code Information Lot number: 06011817 Recalling Firm/ Manufacturer Rubicor Medical 600 Chesapeake Drive Redwood City , California 94063-1712 For Addition Information Contact Lauren Vitelli 650-587-3446 Reason For Recall Devices' sterility may be compromised due to lack of adequate sterilization. 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 in Commerce 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 who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

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