Zyno Medical Z800 Series Infusion Pumps: Faulty Power Supply May Prevent Battery Charging
Certain Zyno Medical Z800 series infusion pumps contain faulty power supply modules that cannot charge the rechargeable battery. When unplugged from AC power, affected pumps may lack sufficient charge to operate.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall. The faulty power supply creates risk of harm by potentially leaving the battery uncharged and preventing the infusion pump from functioning when not connected to AC power. However, no injuries or illnesses have been reported. Per the rubric, risk-of-harm medical devices without reported injuries score at most 3 (High).
Plain-English summary
Zyno Medical has recalled certain Z800, Z800F, Z800W, and Z800WF infusion pumps due to faulty power supply modules. These modules fail to charge the rechargeable battery within the pump.
When the pump is unplugged from AC mains power, the battery may have insufficient or no charge available. This could prevent the pump from delivering medication to patients who depend on continuous or intermittent infusion therapy.
Approximately 88 units have been distributed nationwide. Consumers who use or manage these pumps should contact Zyno Medical LLC for information about service, repair, or replacement options. Healthcare facilities should verify whether they have any of the affected serial numbers and take the pumps out of service if identified.
The recalled product
- Product
- Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 88
Distribution
Distributed nationwide across the United States.
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