Device recall
Z-2668-2026: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT…
FDA device recall · Class II · Bard Access Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2668-2026 |
|---|---|
| Recall event | 99096 |
| Product | 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.). |
| Product code | FSH |
| Recalling firm | Bard Access Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K813338 |
| FEI number | 3006260740 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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