Recall Z-0523-2025 ยท FRN Pump, Infusion
Zyno Medical LLC
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional.
| Date | Nov 22, 2024 (initiated Sep 30, 2024) |
| Status | Open, Classified |
| Reason | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024. |
| Root cause | Software design (manufacturing process) |
| Action | On September 30, 2024 MEDICAL DEVICE NOTIFICATION letters were sent to customers. Mitigation: Zyno Medical is issuing this customer notification, advising customers that the expected User ID may be missing from completed therapies in the EMR Patient Record. Zyno Medical is planning to correct this issue through an update to the software. Recommended Actions: The user can locate the Patient Order in the Patient Record in the EMR and manually update the record to reflect the administrating clinician s User ID until the Z-800WF pump software version is updated. Follow the guidelines of your facil |
| Quantity | 100 units |
| Distribution | Domestic: AL, FL, LA, MI, NE, NJ, OH, TX. |
| FDA record | Open on fda.gov |