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U.S. Department of Health and Human Services

Class 2 Device Recall Casper Clip Appliers

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  Class 2 Device Recall Casper Clip Appliers see related information
Date Initiated by Firm November 01, 2007
Date Posted January 29, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = AESCULAP, INC.
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