—#108774

Product

Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545, 15562701. Catalog C07150MB Lot No's. 15530113, 15556371, 15560546. Catalog C08120MB Lot No's. 15530112. Catalog C08150MB Lot No's. 15535365, 15556374, 15562702. Indicated for palliation of malignant neoplasms in the biliary tree.

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K031777, K042969, K062798
Affected lot / code info: Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698, 15530115, 15536150, 15556366, 15560543, 15530114, 15556368, 15560545, 15562701, 15530113, 15556371, 15560546, 15530112, 15535365, 15556374, 15562702.

Why it was recalled

Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.

Root cause (FDA determination)

Packaging process control

Action the firm took

Cordis Corp sent a " Urgent Medical Device Recall (Removal) letter dated April 9, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A Response Form was provided with each notification. Customers were asked to complete and return Response Form. The customers were instructed to : " Immediately identify and set aside all product listed above in a manner that ensures the affected product will not be used. " Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. " Either return any affected product with reference to the RA# on the form, or contact your local sales representative, or contact Customer Service (see Available Assistance section) to facilitate return of the affected product. Replacement product will be provided in a short time frame. Credit will be provided for customer-owned inventory upon request. " Pass on this notice to anyone in your facility that needs to be informed. " If any product listed below has been forwarded to another facility, contact that facility to arrange return. " Maintain awareness of this notice until all product listed above has been returned to Cordis. For questions related to the issue or product replacement, please contact your local sales representative, or contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 8:00 PM EDT.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Worldwide Distribution-- USA (nationwide) and the country Canada.

Timeline

Recall initiated: 2012-04-09
Posted by FDA: 2012-05-10
Terminated: 2013-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.