FDA-Device2023-10-25Class I
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
EITAN MEDICAL LTD
Hazard
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Sold states
US nationwide distribution.
Affected count
1383
Manufactured in
29, Yad Kharutsim, N/A, Netanya, N/A, Israel
Products
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief