Z-800 Infusion System (Zyno Medical) – Battery Discharge (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Zyno Medical LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
Zyno Medical LLC is recalling Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion sy due to Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC m. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Recommended Action
Per FDA guidance
Zyno Medical notified consignees on 10/18/2024 via email. Consignees were instructed that the updated notification supersedes current labeling and includes the following instructions: To maintain the health and runtime of the battery, it is recommended to plug the battery into AC Mains in for at least 6 hours every 30 days to fully charge the battery. Additionally, for scenarios where the Z800 pump is left plugged into AC Mains for extended periods of time, it is recommended to unplug for up to 5 seconds and re-plug the Z800 pump back into AC Mains at least every 30 days to activate the internal battery charger and ensure an expected operating time on battery power. Customers were also asked to provide acknowledgement of receipt.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026