Device recall
Z-0948-2007: ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size…
FDA device recall · Class II · Conmed Endoscopic Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0948-2007 |
|---|---|
| Recall event | 37905 |
| Product | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 4cm; product code/end item #000849 and #000859 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821. |
| Product code | KNQ |
| Recalling firm | Conmed Endoscopic Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 30, 2010 |
| 510(k) numbers | K033936 |
| FEI number | 1000159712 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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