Device recall
Z-0363-2017: X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE…
FDA device recall · Class II · C.R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-0363-2017 |
|---|---|
| Recall event | 75452 |
| Product | X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is… |
| Product code | LJE |
| Recalling firm | C.R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2021 |
| 510(k) numbers | K063632 |
| FEI number | 1018233 |
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