Device recall
Z-2442-2012: Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-2442-2012 |
|---|---|
| Recall event | 62927 |
| Product | Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream… |
| Product code | LOX |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 26, 2013 |
| PMA numbers | P880003 |
| FEI number | 1016427 |
At a glance
- None 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