Device recall
Z-1468-2021: Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to…
FDA device recall · Class II · Trinity Sterile, Inc.
Key facts
| Recall number (Z-number) | Z-1468-2021 |
|---|---|
| Recall event | 87538 |
| Product | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l |
| Product code | OXQ |
| Recalling firm | Trinity Sterile, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2023 |
| FEI number | 1000123297 |
At a glance
- None 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