Product is labeled in part: Inner Label "***SMART Control… recallZ-1508-2012 · Cordis Corporation · initiated Apr 9, 2012

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.

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number

Z-1508-2012

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Apr 9, 2012

Posted by the FDA

May 10, 2012

Recalling firm

Cordis Corporation

Quantity

278 units

Product code

FGE

FDA submissions

K031777, K042969, K062798

Distribution

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

Product description

Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL 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. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB Lot No. 15535360. Catalog C10080SB Lot No. 15530747. Catalog C12030SB Lot No. 15530756. Catalog C12040SB Lot No. 15530755. Catalog C12060SB Lot No's. 15535363, 15569685. Catalog C12080MB Lot No. 15530757 Catalog C14040SB Lot No's. 15530754, 15557313. Catalog C14060SB Lot No's. 15530753, 15557311. Catalog C14080SB Lot No. 15535361. Indicated for palliation of malignant neoplasms in the biliary tree.

Other devices under the same FDA submission

2 devices cleared under K031777, K042969, K062798 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• S.M.A.R.T. C10080SB

  Cordis US Corp. · Stents, Drains And Dilators For The Biliary Ducts
  1 death2 reports
• S.M.A.R.T. C09080MB

  Cordis US Corp. · Stents, Drains And Dilators For The Biliary Ducts
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 61713).

• Z-1507-2012 · Terminated
  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**…