Company: EITAN MEDICAL LTD
Date of Enforcement Report: 10/19/2023
Class I
PRODUCT
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Recall Number:
Z-0094-2024
REASON:
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
RECALLING FIRM/MANUFACTURER:
EITAN MEDICAL LTD
VOLUME OF PRODUCT IN COMMERCE:
1383
DISTRIBUTION:
US nationwide distribution.
