EITAN Medical recalls Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 due to potential air embolism from undetected air in lines. Affected models include Multi-Therapy, Epidural, and SapphirePlus.
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
EITAN Medical is recalling Sapphire Infusion Pumps with specific software revisions that may fail to detect air in the infusion line, risking air embolism. This could cause serious health issues if air enters the bloodstream during treatment.
The pumps may not detect air in the infusion line, which can enter the bloodstream and cause air embolism. This is a serious medical condition that could lead to complications or death if not addressed.
Patients using these pumps for medical treatments are most at risk. Healthcare providers who administer these pumps should check if their devices have the affected software revisions.
Check the software revision number on the pump's label. Affected models include Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027), and SapphirePlus (REF 15038-000-0001).
Look for software revision numbers 16.10.1 or 16.10.2 on the pump's label or documentation.
Reach out to EITAN Medical for guidance on next steps if the pump has the affected software revision.
Software revisions 16.10.1 and 16.10.2 are affected.
Check the software revision number on the pump's label; affected models include Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027), and SapphirePlus (REF 15038-000-0001).
No immediate stop is required, but you should check the software revision and contact EITAN Medical if affected.
We’ve drafted a message you can send EITAN Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0094-2024 — EITAN Medical EITAN Medical Hello, I own a EITAN Medical that is covered by recall Z-0094-2024 from EITAN Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
