Recall Z-1183-2024 ยท FRN Pump, Infusion
Zyno Medical LLC
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
| Date | Feb 23, 2024 (initiated Dec 20, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Zyno Medical LLC issued URGENT: Medical Device Correction Zyno Medical Z-800WF Infusion Pump -Alarm Volume Reversion Issue letter on 12/20/23 via Certified Mail. Letter states reason for recall, health risk and action to take: To address this issue, users can reset the alarm volume by accessing the Factory Settings (2) via the configuration menu on the pump and selecting the desired alarm volume. The chosen setting will remain on the pump until it is manually altered or until the initial workflow that triggered the reversion is repeated. Zyno Medical LLC is mitigating this alarm issue by condu |
| Quantity | 574 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130690 | Z-800 INFUSION SYSTEM Zyno Medical, LLC, Jun 12, 2013 |