FDA recall Z-0094-2024

Product

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

US nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-09-11

Report date

2023-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Netanya, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2024