Zyno Medical Recalls Z-800 Volumetric Infusion Systems for Software Update
Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but involves a software and documentation update rather than a physical defect causing injury, fitting the criteria for a voluntary precautionary recall or minor labeling/documentation issue.
Plain-English summary
Zyno Medical LLC is recalling 2,589 units of the Z-800 Volumetric Infusion System. These devices are used for the intravenous infusion of parenteral fluids, blood, and blood products to human patients. The recall is being conducted to update the Instruction For Use regarding the Preventative Maintenance (PM) schedule and to add Odometer software that monitors the accumulative fluid volume infused by the pump.
The affected units were distributed nationwide. The recall covers specific lot numbers ranging from 20080416-zs5 to 20110505-SH. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities and users should contact Zyno Medical LLC for instructions on how to update the devices. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
- Manufacturer
- Zyno Medical LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 2,589
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 (20)
- LOT # 20080416-zs5
- 20080711-zs5
- 20080826-zs5
- 20081022-zs5
- 20090126-zs5 20090320-zs5
- 20090507-zs5
- 20090612-zs5
- 20090706-zs5
- 20090910-zs5 20091110-zs5
- 20100106-C
- 20100420-D
- 20100729
- 20101005-BJ 20100910-SH
- 20101013-SH
- 20101206-SH
- 20110110-SH
- 20110111-SH 20110204-SH
- 20110210-SH
- 20110308-SH
- 20110505-SH
Distribution
Distributed nationwide across the United States.
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