FDA Device recall Z-1183-2024
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a…
- FDA Device
- Class II
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a… by Zyno Medical, citing when utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1183-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-20 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zyno Medical |
| Distribution | US |
Product
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Reason
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
Identifiers
| code_info | UDI: 00814371020037 software version 5.2.05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1183-2024%22
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