Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By**
FDA device recall Z-1508-2012 · posted 2012-05-10 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 278 units
- Distribution
- Worldwide Distribution-- USA (nationwide) and the country Canada.
- Date initiated
- 2012-04-09
- Date posted
- 2012-05-10
- Date terminated
- 2013-12-24
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798) | Cordis Corp. | 2008-02-06 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K042969) | Cordis Corp. | 2004-11-08 |
| MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031777) | Cordis Corp. | 2003-07-07 |