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Recall Observatory FDA recall evidence

Device product

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

Z-0094-2024

September 11, 2023

Class I

Product summary

Firm
EITAN MEDICAL LTD
Event
Event 93105
Status
Ongoing
Classification
Class I
Quantity
1383
Official record key
device-enforcement:Z-0094-2024

Official wording

Reason: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

Code information: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software revision may fail to detect air in line, which may