Device recall
Z-0044-2018: BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-0044-2018 |
|---|---|
| Recall event | 78224 |
| Product | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues. |
| Product code | KNW |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2018 |
| 510(k) numbers | K133948 |
| FEI number | 2020394 |
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