Device recall
Z-1057-2022: OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
FDA device recall · Class II · SIMPLIVIA HEALTHCARE LTD.
Key facts
| Recall number (Z-number) | Z-1057-2022 |
|---|---|
| Recall event | 89952 |
| Product | OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143 |
| Product code | ONB |
| Recalling firm | SIMPLIVIA HEALTHCARE LTD. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K192866 |
| FEI number | 3002807615 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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