EITAN MEDICAL LTD recalls Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (RE…
- Recall date
- September 11, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0094-2024
- FDA classification
- Class I
- Brand / firm
- EITAN MEDICAL LTD
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
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