FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
Brand
Rubicor Medical
UPC
Lot number: 06011817

Units Affected

19 units