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
15031-000-0028/729010915010915032-000-0027/729010915014715038-000-0001/7290109150161
- 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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