Zyno Medical Z800 Infusion Pump Recall Details Danger of Air Embolism
The affected pumps, according to the company, include a defect in the air-in-line software algorithm that may allow a 1.0 ml air bubble to be passed on to a patient.
Zyno Medical recently reported it is removing its Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps due to a software defect which may cause harm. The recall has been identified as Class I by FDA. The Z800 infusion systems are intended to provide infusion intravenously of nutrition or essential fluids, blood, and blood products.
The company is recalling the specified pumps due to a defect in the air-in-line software algorithm that may allow a 1.0 ml air bubble to be passed on to a patient. Use of recalled products may result in air entering the blood vessels, fast and irregular heartbeat, heart attack, stroke, seizure, and death. Zyno has reported two injuries, and no deaths related to the issue.
On Sept. 13, Zyno sent all affected customers an Urgent Medical Device Correction letter recommending that all devices included in the removal should cease being used.
Once a product is identified as being part what is being removed, a representative from Zyno’s partner company, Intuvie, will contact customers to coordinate device exchange instructions.
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