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U.S. Department of Health and Human Services

Class 2 Device Recall Rubicor

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  Class 2 Device Recall Rubicor see related information
Date Initiated by Firm February 17, 2006
Date Posted April 11, 2006
Recall Status1 Terminated 3 on May 11, 2006
Recall Number Z-0715-06
Recall Event ID 34859
510(K)Number K020047  K023601  K030049  K032584  K052506  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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 CA 94063-1712
For Additional Information Contact Lauren Vitelli
650-587-3446
Manufacturer Reason
for Recall		 Devices' sterility may be compromised due to lack of adequate sterilization.
FDA Determined
Cause 2		 Other
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = RUBICOR MEDICAL, INC.
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