FDA Device recall Z-0094-2024
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
- FDA Device
- Class I
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class I recall of Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001) by Eitan Medical, citing infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0094-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-11 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Eitan Medical |
| Distribution | US |
Product
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Reason
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Identifiers
| code_info | Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0094-2024%22
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