EITAN MEDICAL LTD: Medical Device Recall in 2023 - (Recall #: Z-0094-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 11, 2023

Date Posted: October 25, 2023

Recall Number: Z-0094-2024

Event ID: 93105

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1383

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.

Voluntary or Mandated:

Voluntary: Firm initiated