Device recall
Z-0085-2027: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10…
FDA device recall · Class II · Stryker Sustainability Solutions
Key facts
| Recall number (Z-number) | Z-0085-2027 |
|---|---|
| Recall event | 99655 |
| Product | BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 |
| Product code | NLH |
| Recalling firm | Stryker Sustainability Solutions |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030187 |
| FEI number | 3009350690 |
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