Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Reported: October 25, 2023 Initiated: September 11, 2023 #Z-0094-2024
Product Description
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.
Details
- Recalling Firm
- EITAN MEDICAL LTD
- Units Affected
- 1383
- Distribution
- US nationwide distribution.
- Location
- Netanya, N/A
Frequently Asked Questions
What product was recalled? ▼
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001). Recalled by EITAN MEDICAL LTD. Units affected: 1383.
Why was this product recalled? ▼
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Critical. Recall number: Z-0094-2024.
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