The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind.
Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, 2023, and it affected 1,383 devices in the U.S.
According to an FDA notice, the company recalled the pumps due to software issues with version Rev 16.10. Pumps with this software version may fail to detect air in the line when running on battery power. In some cases, the pump may not sound an alarm when air enters the line.
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