Zyno Medical recalls select IV infusion pumps due to risk for air bubbles
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Key takeaways:
- Zyno Medical is recalling select infusion pumps due to a software defect that may cause air bubbles to be passed to patients.
- The FDA confirmed two reported injuries and no deaths.
Zyno Medical is recalling select Z800 infusion pumps due to a defect in the air-in-line software algorithm that may allow a 1 mL air bubble to be passed on to a patient, according to the FDA.
The use of the affected product may cause serious adverse health consequences, including vascular air embolism, tachyarrhythmia, myocardial infarction, stroke, seizure and death. There have been two reported injuries and no reports of death, the FDA said in a press release.
Image: Adobe Stock.
According to the release, Zyno Medical Z800 infusion systems are intended to provide IV nutrition or parenteral fluids, blood and blood products "under the direction or supervision of a health care professional."
The FDA has identified this recall as class I, the most serious type, meaning the device may cause serious injury or death with continued use.
The recall includes four pump models:
- Z-800 (00814377102006)
- Z-800W (00814371020020)
- Z-800F (00814371020013)
- Z-800WF (00814371020037)
On Sept. 13, Zyno Medical sent all affected customers an urgent medical device correction letter recommending customers stop using affected devices and follow instructions to return the devices for software update.
A representative from Intuvie LLC, Zyno Medical’s partner company, will contact customers to coordinate instructions for exchanging devices, the release said.
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