Class 2 Device Recall Zyno

• Date Initiated by Firm: December 20, 2023
• Date Posted: February 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1183-2024
• Recall Event ID: 93857
• 510(K)Number: K130690
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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
• Code Information: UDI: 00814371020037 software version 5.2.05
• Recalling Firm/ Manufacturer: Zyno Medical LLC; 177 Pine St; Natick MA 01760-1331
• For Additional Information Contact: SAME; 508-650-2008
• Manufacturer Reason for Recall: 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
• FDA Determined 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 conducting a voluntary medical device correction to downgrade the software from version 5.2.05 to version 5.1.87. Please note that the low volume alarm issue occurred with a specific software change that occurred in version 5.2.05 and the issue does not exist. Complete the attached Zyno Medical Z-800WF Infusion Pump - Alarm Volume Reversion Issue -Response Verification Form. This will include checking your inventory for affected products, verifying serial numbers, confirming product location, reporting any transferred product, and signing and dating the completed form. 3. A representative from Zyno Medical's distribution partner, lntuvie LLC, will be in contact with you to coordinate instructions on exchanging devices and the timing to remediate this action. 4. Pass this notice to the appropriate healthcare professional within your facility who needs to be informed and to any facility where the potentially affected devices have been transferred (if appropriate). Provide Zyno Medical with details of any affected devices that have been transferred to other facilities. If you have any questions or would like assistance, please contact your local Business Development Manager
• Quantity in Commerce: 574 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN