Device recall
Z-0509-2010: IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model…
FDA device recall · Class II · Numed Inc
Key facts
| Recall number (Z-number) | Z-0509-2010 |
|---|---|
| Recall event | 53495 |
| Product | IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured for: B. Braun Interventional Systems Inc., 824 Twelfth Avenue Bethlehem, PA18018 --- Manufactured by: NuMED, Inc. 2880 Main… |
| Product code | LIT |
| Recalling firm | Numed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K931009 |
| FEI number | 1318694 |
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