CLASS I ONGOING Device recall · Reported 25 Oct 2023 · FDA Enforcement Report
Sapphire Infusion Pumps recalled by Eitan Medical
Eitan Medical is recalling Sapphire Infusion Pumps, distributed nationwide in the US. The recall was initiated on 11 Sep 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0094-2024
- FDA event ID
- 93105
- Recalling firm
- Eitan Medical, Netanya, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Sep 2023
- FDA classified
- 19 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Infusion Pumps
Timeline
| 11 Sep 2023 | Recall initiated by company | |
| 19 Oct 2023 | Classified by FDA | +38 days |
| 25 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Where it was distributed
US nationwide distribution.
Questions about this recall
Is Sapphire Infusion Pumps recalled?
Yes. Eitan Medical recalled Sapphire Infusion Pumps on 11 Sep 2023. The recall is Class I and its status is Ongoing. Recall number Z-0094-2024.
Why was it recalled?
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
Which lots are affected?
Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109, 15032-000-0027/7290109150147, 15038-000-0001/7290109150161
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |