Home / Recalls / Medical Devices
EITAN MEDICAL LTD recalls Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF
Recalled October 25, 2023 · FDA recall Z-0094-2024 · EITAN MEDICAL
Hazard
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism. · FDA Class I
Units
1383
Sold at
US nationwide distribution.
Description
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Product
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Manufacturer(s)
EITAN MEDICAL LTD
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →