The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Please be aware, this recall is a voluntary correction, not a product removal.
Eitan Medical Ltd will be updating affected devices to address this issue.
- Product Name: Eitan Medical Ltd Sapphire Infusion Pumps running software version Rev 16.10
- Product Models:
- Devices Recalled in the U.S.: 1,383
- Date Initiated by Firm: September 11, 2023
The Sapphire infusion pumps deliver fluids, nutrition, including lipids, as well as medication, blood, and blood products such as platelets and plasma. The pumps are designed to be used in hospitals, clinics, at home, or they may be portable. The pumps run under both battery power and when connected to a power source.
Reason for Recall
Eitan Medical Ltd is recalling the Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues in software 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 there is air in the line.
Failure to detect air in the line can lead to blockage in a blood vessel (embolism), causing complications such as unstable blood pressure, stroke, heart attack, or even death.
There have been no reports of injury or death associated with this issue.
Who May be Affected
- People who use the Sapphire infusion pumps listed in the recall
- Health care workers who use or recommend the pumps for their patients
What to Do
On September 11 and 12, 2023, Eitan Medical Ltd sent a letter to Directors of Nursing, Pharmacy, Biomedical Engineering, and Risk Management.
The letter asked people to:
- Stop using the recalled Sapphire Infusion Pumps on battery power.
- Connect the devices to a power supply, like continuous AC power.
- Add an air-eliminating filter to the device.
Eitan Medical Ltd has traced the problem to an issue with software version Rev 16.10. The company no longer offers that software version. A new software update that corrects the problem should be available in four months.
Customers in the U.S. with questions about this recall should contact Eitan Medical Ltd Customer Service by phone at 1-877-541-9944 or by email at firstname.lastname@example.org.
To report adverse events or product complaints, email email@example.com.
Full List of Affected Devices
- Eitan Medical Ltd Sapphire Infusion Pumps with the Product Models:
- Medical Device Recall Database Entries:
- Eitan Medical Ltd Sapphire Recall Letter
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.