Oct

2023

FDA Recall: Infusion Pumps with affected software revision may fail to detect air in line, may lead to air embolism

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.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Infusion Pumps with affected software revision may fail to detect air in line, may lead to air embolism

Allison Pate

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