Class 2 Device Recall Centrica

• Date Initiated by Firm: May 13, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on September 15, 2003
• Recall Number: Z-0935-03
• Recall Event ID: 26324
• 510(K)Number: K022879
• Product Classification: Instrument, Biopsy - Product Code KNW
• Product: Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
• Code Information: Lot #: 28090403, 03-0085, 03-0086, C030401
• Recalling Firm/ Manufacturer: Sanarus Medical Inc; 5880 West Las Positas Suite 52; Pleasanton CA 95488
• Manufacturer Reason for Recall: Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
• FDA Determined Cause: Other
• Action: On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
• Quantity in Commerce: 83 units
• Distribution: Product was released for distribution to 10 consignees. 83 units from the lot had been shipped to consignees. The U.S. States include: MD, TN, TX, OH, and IL. The recall was appropriately extended to the user level; i.e., clinics, hospitals and medical centers 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 = KNW