Z-800 Infusion System (Zyno Medical) – Air-in-Line Software Defect (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Zyno Medical LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Zyno Medical LLC is recalling Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 due to There is a defect in the air-in-line software algorithm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a defect in the air-in-line software algorithm.
Recommended Action
Per FDA guidance
An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated 9/13/24 was sent to customers. Mitigation Zyno Medical LLC is mitigating this software issue by conducting a voluntary medical device correction to remove the faulty software and correctly install software that is free of this defect. Recommended Actions 1. Actions to Address the Issue During Use Note that only the devices listed in this letter are affected. No other products are involved in this action. Discontinue use of the affected device and proceed to the instructions for return of the device in Recommended Action below. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF Infusion Pump Air-in-Line Software Issue Response Verification Form. This will include checking your inventory for the affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. A representative from Zyno Medical s partner company, Intuvie LLC, will be in contact with you to coordinate instructions on exchanging devices to remediate this action. Pass this notice to the appropriate personnel who need to be informed if the identified devices have been transferred to another location. If you have any questions or would like assistance, please contact your local Business Development Manager. Contact Information: Customerservice@intuvie.com ***Update 1/3/2025***Additional consignees were sent URGENT: CLASS 1 RECALL letters due to additional affected units identified. Recommended Actions 1. Actions to Address the Issue During Use Note that only the devices listed in this letter are affected. No other products are involved in this action. Discontinue use of the affected device and proceed to the instructions for return of the device in Recommended Action below. 2. Actions to Correct the Issue Complete the attached Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF I
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026