Zyno Medical Z800 Large Volume Infusion Pumps -Intended recall: Software Issue
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient…
Why was Zyno Medical Z800 Large Volume Infusion Pumps -Intended 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00814371020037 software version 5.2.05
- Product
- Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient…
- Recalling firm
- Zyno Medical LLC
- Quantity
- 574 units
- Distribution
- Nationwide
- Recall date
- March 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)