Device recall
Z-1887-2013: Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat…
FDA device recall · Class I · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1887-2013 |
|---|---|
| Recall event | 65482 |
| Product | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB… |
| Product code | DTK |
| Recalling firm | Cordis Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 27, 2014 |
| 510(k) numbers | K034050, K091077 |
| FEI number | 1016427 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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