Device recall
Z-1012-2025: Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL…
FDA device recall · Class II · Trinity Sterile, Inc.
Key facts
| Recall number (Z-number) | Z-1012-2025 |
|---|---|
| Recall event | 96068 |
| Product | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No |
| Product code | OXQ |
| Recalling firm | Trinity Sterile, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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