Device recall
Z-0010-2013: 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The…
FDA device recall · Class II · C.R. Bard, Inc., Urological Division
Key facts
| Recall number (Z-number) | Z-0010-2013 |
|---|---|
| Recall event | 63136 |
| Product | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. |
| Product code | KOD |
| Recalling firm | C.R. Bard, Inc., Urological Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2013 |
| 510(k) numbers | K821745 |
| FEI number | 1018233 |
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