Device recall
Z-0562-2019: CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08…
FDA device recall · Class II · CIVCO Medical Instruments Co., Inc.
Key facts
| Recall number (Z-number) | Z-0562-2019 |
|---|---|
| Recall event | 81361 |
| Product | CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA. |
| 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