Class I — EITAN MEDICAL LTD
| Recalling firm | Eitan Medical LTD |
|---|---|
| Registered facility | Eitan Medical LTD (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. |
| Product | Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) |
| Quantity | 1383 |
| Distribution | US nationwide distribution. |
| Initiated | 2023-09-11 |
| Classified | 2023-10-19 |
| Recall number | Z-0094-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — EITAN MEDICAL LTD (Z-0094-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93105/
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