Device recall
Z-1396-2016: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-1396-2016 |
|---|---|
| Recall event | 73249 |
| Product | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions. |
| Product code | FCG |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2016 |
| 510(k) numbers | K936194 |
| FEI number | 2020394 |
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