Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0094-2024 — Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

U.S. FDA — Device Enforcement · Israel · 2023-09-11 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0094-2024
Date of alert
2023-09-11
Country / jurisdiction
Israel
Risk level
Class I
Risk type
recall
Brand
EITAN MEDICAL LTD
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7290109150109
Reported risk: Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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