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U.S. Department of Health and Human Services

Class 2 Device Recall Z800 Infusion System

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 Class 2 Device Recall Z800 Infusion Systemsee related information
Date Initiated by FirmOctober 18, 2024
Date PostedNovember 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0506-2025
Recall Event ID 95601
510(K)NumberK100705 K130690 
Product Classification Pump, infusion - Product Code FRN
ProductZ-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.
Code Information 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.
FEI Number 3006575795
Recalling Firm/
Manufacturer		 Zyno Medical LLC
177 Pine St
Natick MA 01760-1331
For Additional Information ContactMatthew King
603-459-9755
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionZyno 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.
Quantity in Commerce34,994 units
DistributionThis product is distributed only in the United States.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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