Class 3 Device Recall Z800 Infusion System

• Date Initiated by Firm: September 30, 2024
• Date Posted: November 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0523-2025
• Recall Event ID: 95635
• 510(K)Number: K100705 K130690
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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.
• Code Information: Model/Catalog Number: Z-800WF; UDI-DI: 00814371020006; Serial Numbers: 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371, 500373, 500374, 500375, 500376, 500377, 500378, 500384, 500385, 500386, 500388, 500389, 500390, 500391, 500392, 500393, 500394, 502634, 503435, 503716, 503799, 503917, 503921, 504534, 504807, 504808, 504809, 504810, 504811, 504812, 504813, 504814, 504815, 504816, 504817, 504818, 504819, 504820, 504821, 504822, 504823, 504824, 504825, 504826, 504827, 504828, 504829, 504830, 504831, 504832, 504834, 504835, 504836, 504838, 505369, 505425, 505430, 505432, 505437, 505626, 505627, 505628, 505629, 505630, 505631, 505632, 505633, 505635, 505637, 505638, 505691, 505692, 505693, 506585, 506982, 506983.
• Recalling Firm/ Manufacturer: Zyno Medical LLC; 177 Pine St; Natick MA 01760-1331
• For Additional Information Contact: 508-650-2008
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 facility for performing manual updates in the EMR. Reporting Adverse Events: We strongly encourage healthcare providers and patients to promptly report any adverse events associated with the use of the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pump. Please send your reports to Zyno Medical via email to feedback@intuvie.com. Additionally, we urge you to report any negative side effects related to the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pumps to the FDA. You can submit your report online at www.fda.gov/medwatch or by calling 1-800-FDA-1088. Your cooperation in reporting these events is vital for continuous safety monitoring of medical devices. For information about the Zyno Medical Z-800, Z-800F, Z-800W, and/or Z-800WF Infusion Pumps, including benefits and risks, refer to the Zyno Medical Z-800 Infusion Pump Instructions for Use (Z-800 800-IFU-6651, Z-800F 800-IFU-2602, Z-800W 800W-IFU-3614, and Z-800WF 800WF-IFU-4602) for complete description of the benefits and risks of using the Zyno Medical Z-800 family of pumps. Zyno Medical is committed to offering products which meet the highest quality standards and to continuous improvement in the interest of patient safety. We regret any inconvenience that this action may cause, but believe transparent communication will ensure you have timely, relevant information for managing your patients. If you
• Quantity in Commerce: 100 units
• Distribution: Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
• 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