Zyno's Recent Recall: Specific Z-800 Infusion Pumps Removed Due to Software Deficiency

Zyno’s Recent Recall: Specific Z-800 Infusion Pumps Removed Due to Software Deficiency

Zyno's Recent Recall: Specific Z-800 Infusion Pumps Removed Due to Software Deficiency

This recall pertains to the removal of specific devices from their places of usage or sale. The FDA has classified this recall among the most severe types, indicating potential serious injury or even death if the device continues to be utilized.

Products Affected 

Pump Model

Unique Device Identifier (UDI-DI)  

Software Revision

Z-800

00814377102006 

6.1.01 and 6.1.07z

Z-800W

00814371020020

3.1.32 and 3.1.64z

Z-800F

00814371020013  

4.1.02 and 4.1.08z

Z-800WF

00814371020037

5.1.01 and 5.1.08z

Steps to Follow  

  • Cease using the affected infusion pumps immediately. 

On September 13, 2024, Zyno Medical LLC issued an Urgent Medical Device Correction letter to all impacted clients, outlining the following actions: 

  • Discontinue usage of the affected devices.
  • Adhere to the instructions provided for returning devices for a software update.
  • Complete the Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF Infusion Pump – Air-in-Line Software Issue – Response Verification Form, which includes:
    • Inventory check for affected products.
    • Verification of serial numbers.
    • Confirmation of product locations.
    • Notification of any product transfers.
    • Signing and dating the completed form. 
  • Ensure this notice is disseminated to all relevant parties, including those at different locations where devices may have been transferred. 

A representative from Intuvie LLC, a partner of Zyno Medical, will reach out to customers to facilitate the exchange of devices.

Reason for the Recall   

Zyno Medical is conducting a recall of specific Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps due to a defect in the air-in-line software algorithm that could allow a 1.0 mL air bubble to be delivered to a patient. 
 
This defect may lead to serious health risks, including air entering the blood vessels (vascular air embolism), rapid and irregular heartbeats (tachyarrhythmia), heart attack (myocardial infarction), stroke, seizure, and potentially death. 
  
There have been two reported injuries, with no fatalities documented.

Intended Use of the Device 

The Zyno Medical Z800 Infusion Systems are designed to provide intravenous infusion of nutrition or essential fluids, blood, and blood products under the guidance or supervision of qualified health care professionals.

Contact Details  

For any inquiries regarding this recall, customers in the U.S. should reach out to their Zyno Medical local business partner or email feedback@intuvie.com. 

Additional Resources from the FDA (listed by recency):  

Unique Device Identifier (UDI) 

The unique device identifier (UDI) is vital for tracking individual medical devices in the U.S. from manufacture through distribution to patient usage. It enhances reporting accuracy and speed for adverse events, aiding in the identification and resolution of issues promptly. 

Reporting Issues 

Health care professionals and consumers can report any adverse reactions or quality issues they have encountered while using these devices through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.