Device recall
Z-1508-2012: Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1508-2012 |
|---|---|
| Recall event | 61713 |
| Product | 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… |
| Product code | FGE |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| 510(k) numbers | K031777, K042969, K062798 |
| FEI number | 1016427 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database