Home / Recalls / EITAN MEDICAL LTD / Z-0094-2024

Z-0094-2024 Class I Ongoing

Recalled by EITAN MEDICAL LTD — Netanya, N/A

Recall Details

Product Type
Devices
Report Date
October 25, 2023
Initiation Date
September 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1383

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.

Distribution Pattern

US nationwide distribution.

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