Device recall
Z-0570-2019: CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable…
FDA device recall · Class II · CIVCO Medical Instruments Co., Inc.
Key facts
| Recall number (Z-number) | Z-0570-2019 |
|---|---|
| Recall event | 81361 |
| Product | CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx. |
| Product code | ITX |
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| 510(k) numbers | K030064 |
| FEI number | 3012763756 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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