Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction
Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a medical device with potential for serious patient harm, including organ failure and death risk in extreme cases. No illnesses or injuries have been reported. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Zyno Medical LLC is recalling the Z800 Large Volume Infusion Pump (Model Z-800WF) with software version 5.2.05. The pump is intended to deliver intravenous infusions of parenteral fluids, blood, and blood products under medical supervision.
When the patient query feature is used, the alarm volume may inadvertently revert from a higher setting to a low one. This can cause delays in recognizing and responding to therapy issues.
In extreme cases, these delays could result in organ failure or death. Healthcare facilities using affected pumps should contact Zyno Medical for information about remediation options.
The recalled product
- Product
- 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
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion Pumps
- Hazard
- alarm-malfunction
- therapy-delay
- organ-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00814371020037 software version 5.2.05
Distribution
Distributed nationwide across the United States.
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