Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended
Summary
The FDA issued a Class II for Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. by Zyno Medical LLC. Reason: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC m.
Details
Source
Device Recall
External ID
Z-0506-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.
Lot/Code Info: Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200.
Quantity Affected: 34,994 units
Reason for Recall
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Distribution
This product is distributed only in the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-18
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 280 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-0506-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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