Recall Z-0094-2024— EITAN MEDICAL LTD

Name: FDA recall Z-0094-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-11

Class I · Ongoing

Class I FDA medical device recall by EITAN MEDICAL LTD, initiated 2023-09-11. It names one FDA 510(k) clearance: K192860. Product: Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001). Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism..

Recalling firm: EITAN MEDICAL LTD
Classification: Class I
Status: Ongoing
Initiated: 2023-09-11
Firm location: Netanya, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K192860 — Sapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd.·cleared 2020-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.