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U.S. Department of Health and Human Services

Class 2 Device Recall Zyno

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  Class 2 Device Recall Zyno see related information
Date Initiated by Firm December 20, 2023
Date Posted February 23, 2024
Recall Status1 Open3, 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/
Zyno Medical LLC
177 Pine St
Natick MA 01760-1331
For Additional Information Contact SAME
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 2
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 and Original Applicant = ZYNO MEDICAL LLC