Device recall
Z-0536-2018: PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen…
FDA device recall · Class II · Bard Access Systems Inc.
Key facts
| Recall number (Z-number) | Z-0536-2018 |
|---|---|
| Recall event | 79070 |
| Product | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. |
| Product code | LJS |
| Recalling firm | Bard Access Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2021 |
| 510(k) numbers | K162443 |
| FEI number | 3006260740 |
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