medical Class I Updated 2023-10-25

EITAN MEDICAL LTD recalls Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-00

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
View official government recall

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