S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the
FDA device recall Z-1039-2012 · posted 2012-02-15 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.
- Action taken
- All affected consignees were notified by an "Urgent Medical Device Recall (Removal) Letter" dated January 31, 2012 and mailed by overnight delivery on February 1st and 2nd, 2012. Consignees were instructed to identify and quarantine affected product; review, complete, sign, and return an Acknowledgement Form; return the affected product per instructions. Questions should be directed to Customer Service at (800) 551-7683.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 18,000 units
- Distribution
- Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
- Date initiated
- 2012-01-31
- Date posted
- 2012-02-15
- Date terminated
- 2014-08-08
- 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 |
|---|---|---|
| MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031777) | Cordis Corp. | 2003-07-07 |