FDA Device recall Z-0005-2025
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF
- FDA Device
- Class I
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class I recall of Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF by Zyno Medical, citing there is a defect in the air-in-line software algorithm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-09-13 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zyno Medical |
| Distribution | US |
Product
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Reason
There is a defect in the air-in-line software algorithm.
Identifiers
| code_info | UDI-DI: Z-800 - 00814371020006 Z-800W - 00814371020020 Z-800F - 00814371020013 Z-800WF - 00814371020037 Lot N…UDI-DI: Z-800 - 00814371020006 Z-800W - 00814371020020 Z-800F - 00814371020013 Z-800WF - 00814371020037 Lot Numbers: 190722360 20110921-SH 20111005-SH 20111102-SH 20111212-SH 20120105-SH 20120222-SH 20120501-SH 20120612-SH 20120719-SH 20120809-SH 20190809-SH 20120910-SH-1 20121213-sh 20130123-SH 20130227-SH 20120417-SH 20130511-SH 20130517-SH 20130609-SH 20130701-SH 20130812-SH 20131024-SH |
|---|
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-0005-2025%22
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