Z-800 Volumetric Infusion System — Class II medical device recall Z-1024-2013
Terminated recall by Zyno Medical LLC, reported 2013-04-10, distributed nationwide. Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to mon
| Recall number | Z-1024-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2011-06-13 |
| Classified | 2013-03-29 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2016-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 2,589 units |
| Reason classes | software |
| Lot numbers | 20080416-ZS5, 20080711-ZS5, 20080826-ZS5, 20081022-ZS5, 20090126-ZS5, 20090320-ZS5, 20090507-ZS5, 20090612-ZS5, 20090706-ZS5, 20090910-ZS5, 20091110-ZS5, 20100106-C, 20100420-D, 20100729, 20100910-SH, 20101005-BJ, 20101013-SH, 20101206-SH, 20110110-SH, 20110111-SH, 20110204-SH, 20110210-SH, 20110308-SH, 20110505-SH |
Product
Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient.
Reason for recall
Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1024-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.