Class 2 Device Recall Casper Clip Appliers

• Date Initiated by Firm: November 01, 2007
• Date Posted: January 29, 2008
• Recall Status: Terminated on March 28, 2008
• Recall Number: Z-0708-2008
• Recall Event ID: 46142
• 510(K)Number: K940970
• Product Classification: Aneurysm Clip Appliers - Product Code HCI
• Product: Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
• Code Information: Part #: FT420T
• Recalling Firm/ Manufacturer: Aesculap Inc; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Michael Andrews; 800-258-1946 Ext. 5000
• Manufacturer Reason for Recall: Breakage: the inner rod of the applier may corrode and break
• FDA Determined Cause: Device Design
• Action: The recalling firm issued an Import Recall Notice, on or about December 18, 2007, to all their customers to inform them of the problem and the need to return the devices .
• Quantity in Commerce: 60 clips
• Distribution: Worldwide- USA hospitals in AZ, CA, CO, IL, KY, MI, MS, ND, NM, NY, OH, OK, PA, TX, VA, WA, and WI, to sales representatives in NC, OK, and MO and shipped to distributors in CA and Canada.
• 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 = HCI