Device recall
Z-0925-2011: DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical…
FDA device recall · Class II · Cook Endoscopy
Key facts
| Recall number (Z-number) | Z-0925-2011 |
|---|---|
| Recall event | 57573 |
| Product | DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic… |
| Product code | FGE |
| Recalling firm | Cook Endoscopy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2011 |
| 510(k) numbers | K101095 |
| FEI number | 1037905 |
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