Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and
Summary
The FDA issued a Class II for Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous i by Zyno Medical LLC. Reason: 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.
Details
Source
Device Recall
External ID
Z-1183-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: 00814371020037 software version 5.2.05
Quantity Affected: 574 units
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
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-20
Company
Natick, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zyno Medical LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zyno Medical LLC have FDA actions?
Zyno Medical LLC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1183-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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