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U.S. Department of Health and Human Services

Class 1 Device Recall Z800WF Infusion System

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 Class 1 Device Recall Z800WF Infusion Systemsee related information
Date Initiated by FirmMay 07, 2025
Date PostedJune 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1868-2025
Recall Event ID 96796
510(K)NumberK100705 K130690 
Product Classification Pump, infusion - Product Code FRN
ProductZ-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Code Information Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.
Recalling Firm/
Manufacturer		 Zyno Medical LLC
177 Pine St
Natick MA 01760-1331
For Additional Information ContactCustomer Service
508-650-2008
Manufacturer Reason
for Recall		Unreleased software versions were installed on distributed devices without verification or validation.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionConsignees received an "URGENT: MEDICAL DEVICE CORRECTION" notification dated 5/7/25 by email. The notification instructs consignees to check their stock for affected devices and to immediately stop use; recalled devices are to be returned to Zyno Medical via the provided Response Verification Form. The recall notice is to be provided to personnel at consignee locations who need to be informed and communicated to facilities to where devices were transferred to. Any questions about this recall action are to be directed via email to Frederick Lee at feedback@intuvie.com. 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.
Quantity in Commerce613 units
DistributionUS Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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