Device recall
Z-1378-2025: Microstream Instructions for Use and Part Number used with - Product…
FDA device recall · Class II · Oridion Medical 1987 Ltd.
Key facts
| Recall number (Z-number) | Z-1378-2025 |
|---|---|
| Recall event | 96309 |
| Product | Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter… |
| Product code | CCK |
| Recalling firm | Oridion Medical 1987 Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181467 |
| FEI number | 3001227743 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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