Device recall
Z-1397-2022: Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for…
FDA device recall · Class I · Bard Access Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1397-2022 |
|---|---|
| Recall event | 90315 |
| Product | Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for… |
| Product code | FMI |
| Recalling firm | Bard Access Systems, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K191976, K203193 |
| FEI number | 3006260740 |
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