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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Precise Nitinol Stent

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  Class 2 Device Recall Cordis Precise Nitinol Stent see related information
Date Initiated by Firm November 07, 2002
Date Posted December 05, 2002
Recall Status1 Terminated 3 on November 25, 2008
Recall Number Z-0323-03
Recall Event ID 25043
510(K)Number K012993  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB, N830SB, N840SB, N920SB, N930SB, N940SB, N1020SB, N1030SB, N1040SB only. This recall also affects Cordis PRECISE Nitinol Stent System, not distributed in the United States, Catalog numbers, N920SC, N930SC, N940SC, N1020SC, N1030SC and N1040SC only.
Code Information All lot numbers of the indicated Product/Catalog numbers.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014
Manufacturer Reason
for Recall		 Field complaints of marker band spacing being out of spec.
FDA Determined
Cause 2		 Other
Action The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.
Quantity in Commerce 10,468
Distribution Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.
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 = FGE and Original Applicant = CORDIS CORP.
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