Eitan Medical is recalling 1,383 Sapphire Infusion Pumps, specifically the Multi-Therapy, Epidural, and SapphirePlus models. These devices, used to deliver fluids and medications, may have a software defect that prevents them from detecting air bubbles in the infusion line. If air is pumped into a patient's bloodstream, it can cause a serious and potentially life-threatening air embolism.
The affected software (versions 16.10.1 or 16.10.2) may fail to trigger an 'Air in Line' alarm. This failure allows air to pass through the pump and into the patient, which can block blood flow in the lungs or brain, leading to severe injury or death.
Manufacturer communication regarding software revision and safety monitoring.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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