Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to pr
FDA device recall Z-0506-2025 · posted 2024-11-21 · Open, Classified
Recall details
- Recalling firm
- Zyno Medical LLC
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 34,994 units
- Distribution
- This product is distributed only in the United States.
- Date initiated
- 2024-10-18
- Date posted
- 2024-11-21
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Z-800 INFUSION SYSTEM (K130690) | Zyno Medical, LLC | 2013-06-12 |
| ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 (K100705) | Zyno Medical, LLC | 2010-07-08 |