Class 1 Device Recall Z800 Infusion System

• Date Initiated by Firm: September 13, 2024
• Date Posted: October 09, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0005-2025
• Recall Event ID: 95382
• 510(K)Number: K100705 K130690
• Product Classification: Pump, infusion - Product Code FRN
• 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
• Code Information: 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
• FEI Number: 3006575795
• Recalling Firm/ Manufacturer: Zyno Medical LLC; 177 Pine St; Natick MA 01760-1331
• For Additional Information Contact: 508-650-2008
• Manufacturer Reason for Recall: There is a defect in the air-in-line software algorithm.
• FDA Determined Cause: Process change control
• Action: 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
• Quantity in Commerce: 34,994 units (1819 units still need correction)
• Distribution: US 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