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
Reported: March 6, 2024 Initiated: December 20, 2023 #Z-1183-2024
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Zyno Medical LLC
- Units Affected
- 574 units
- Distribution
- Nationwide
- Location
- Natick, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zyno Medical LLC. Units affected: 574 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Moderate. Recall number: Z-1183-2024.
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