—#Z-0323-03

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.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K012993
Affected lot / code info: All lot numbers of the indicated Product/Catalog numbers.

Why it was recalled

Field complaints of marker band spacing being out of spec.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2002-11-07
Posted by FDA: 2002-12-05
Terminated: 2008-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #Z-0323-03. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.