Device recall
Z-0848-06: Cook Esophageal Dilator Set --------------------------------------Small label…
FDA device recall · Class III · Cook Endoscopy
Key facts
| Recall number (Z-number) | Z-0848-06 |
|---|---|
| Recall event | 35265 |
| Product | Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter… |
| Product code | KOG |
| Recalling firm | Cook Endoscopy |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 29, 2006 |
| FEI number | 1037905 |
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