Class 2 Device Recall FX Spare Shieldwire Inflators

• Date Initiated by Firm: March 28, 2007
• Date Posted: May 31, 2007
• Recall Status: Terminated on August 30, 2007
• Recall Number: Z-0834-2007
• Recall Event ID: 37701
• 510(K)Number: K061772
• Product Classification: Embolic Protection System - Product Code FRO
• Product: FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
• Code Information: Catalog number 60042-02. Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07, 52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07
• Recalling Firm/ Manufacturer: Kensey Nash Corp; 735 Pennsylvania Dr; Exton PA 19341-1130
• For Additional Information Contact: Robin M. Fatzinger; 484-713-2100
• Manufacturer Reason for Recall: Insufficient wire sealing
• FDA Determined Cause: Other
• Action: On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.
• Quantity in Commerce: 109 units
• Distribution: Worldwide, including USA and Germany.
• 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 = FRO