Device recall
Z-0837-2022: Regard Custom Procedure Kits containing BD Luer Lok Access Devices
FDA device recall · Class III · ROi CPS LLC
Key facts
| Recall number (Z-number) | Z-0837-2022 |
|---|---|
| Recall event | 89710 |
| Product | Regard Custom Procedure Kits containing BD Luer Lok Access Devices |
| Product code | LRS |
| Recalling firm | ROi CPS LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 25, 2022 |
| 510(k) numbers | K991088 |
| FEI number | 3014527682 |
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