Sapphire Infusion Pumps recalled for software air-detection failure
Sapphire Infusion Pumps with software revisions 16.10.1 or 16.10.2 may fail to detect air in the infusion line, potentially causing life-threatening air embolism. Approximately 1,383 units have been distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which per the severity rubric mandates a minimum score of 4. Air embolism resulting from undetected air in the infusion line is a serious, potentially fatal condition requiring immediate clinical attention.
Plain-English summary
Sapphire Infusion Pumps are being recalled due to a software defect that may prevent the device from detecting air in the infusion line. The affected models include Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027), and SapphirePlus (REF 15038-000-0001) with software revisions 16.10.1 or 16.10.2.
The failure to detect air in the infusion line may allow air to enter the bloodstream, potentially causing air embolism, a serious medical emergency that can be life-threatening.
Approximately 1,383 units of these pumps have been distributed nationwide in the United States. Healthcare facilities and patients currently using these devices should follow FDA instructions and manufacturer guidance for device inspection and any necessary corrective actions.
EITAN MEDICAL LTD, the manufacturer, is coordinating with healthcare providers on remediation steps. Healthcare providers or patients with questions should contact their healthcare facility or the manufacturer for guidance.
The recalled product
- Product
- Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
- Manufacturer
- EITAN MEDICAL LTD
- Affected units
- 1,383
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Software Revision: 16.10.1 or 16.10.2 REF/UDI-DI: 15031-000-0028/7290109150109
- 15032-000-0027/7290109150147
- 15038-000-0001/7290109150161
Distribution
Distributed nationwide across the United States.
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