Reported Mar 6, 2024 · Ongoing
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and…
Zyno Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zyno Medical LLC · 177 Pine St · Natick, MA · 01760-1331
Is this the product you have?
- Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified
- health care professional ModelZ-800WF
- Lot codes and dates
- UDI00814371020037 software version 5.2.05
- Amount recalled
- 574 units
Where it was sold
- Nationwide
Why it was recalled
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
This product could cause temporary or reversible health problems — stop using it.
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