Sapphire Infusion Pumps recall: Software Issue
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Why was Sapphire Infusion Pumps recalled?
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
- Recalling firm
- EITAN MEDICAL LTD
- Quantity
- 1383
- Distribution
- US nationwide distribution.
- Recall date
- October 25, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)