This recall involves removing certain devices from use or sale. As the most serious type of recall, it means the device may cause serious injury or death if its use continues.
Zyno Medical told customers that it released certain Z-800, Z-800F, Z-800W and Z-800WF infusion pumps to customers with incorrect software versions. These software versions failed to undergo the required verification and validation testing. As a result, the pumps can experience unexpected performance issues. That includes essential functions and risk measures, like air in line detection, alarm volume and reverse flow prevention.
The company says worst-case scenarios of these failures can result in serious harms like under- or over-delivery of drugs. Air in line can infuse a venous air embolism as well, while it could also lead to the undetected flow reversal of drugs or parenteral fluids. Additionally, lowered keep vein open rates can lead to low flow rates and possibly cause a blood clot to form at the catheter’s distal end.
To date, Zyno reports zero serious injuries or deaths related to the issue.
Zyno told customers to discontinue use of affected devices and follow instructions for its return. The company intends to have a representative contact customers to coordinate device exchanges to remediate the issue.
