Device recall
Z-0094-2024: Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural…
FDA device recall · Class I · EITAN MEDICAL LTD
Key facts
| Recall number (Z-number) | Z-0094-2024 |
|---|---|
| Recall event | 93105 |
| Product | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) |
| Product code | FRN |
| Recalling firm | EITAN MEDICAL LTD |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K192860 |
| FEI number | 3010293992 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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