Device recall
Z-0310-2025: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF…
FDA device recall · Class I · Cardinal Health 200, LLC
Key facts
| Recall number (Z-number) | Z-0310-2025 |
|---|---|
| Recall event | 95487 |
| Product | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 |
| Product code | MEG |
| Recalling firm | Cardinal Health 200, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K192551 |
| FEI number | 3001236905 |
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