FDAFDA · Food and drugs·Recall number Z-1183-2024
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 Model: Z-800WF
Published March 6, 2024 · Recall initiated: December 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zyno Medical LLC
- Distributor
- Nationwide
- Lot
- UDI: 00814371020037 software version 5.2.05
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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