# FDA recall Z-0094-2024

> **EITAN MEDICAL LTD** · Class I · device recall initiated 2023-09-11.

## Product

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

## Reason for recall

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0094-2024
- **Recalling firm:** EITAN MEDICAL LTD
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-11
- **Report date:** 2023-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Netanya, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2024

## Citation

> AI Analytics. FDA recall Z-0094-2024. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0094-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*