Reported Oct 25, 2023 · Ongoing

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

Eitan Medical Ltd.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: EITAN MEDICAL LTD · 29, Yad Kharutsim · Netanya, N/A · N/A

Is this the product you have?

  • Sapphire Infusion Pumps
  • ModelsMulti-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Lot codes and dates
  • Software Revision16.10.1 or 16.10.2
  • REF/UDI-DI
    • 15031-000-0028/7290109150109
    • 15032-000-0027/7290109150147
    • 15038-000-0001/7290109150161
Amount recalled
1383

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Eitan Medical Ltd. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.