Brand Name: Z-800 Infusion System recallZ-0523-2025 · Zyno Medical LLC · initiated Sep 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zyno Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design (manufacturing process)
What the company is doing
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 [email protected]. 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
Recall details
- Recall number
- Z-0523-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2024
- Posted by the FDA
- Nov 22, 2024
- Recalling firm
- Zyno Medical LLC
- Quantity
- 100 units
- Product code
- FRN
- FDA submissions
- K130690, K100705
- Distribution
- Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.
Product description
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 (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Z-800Zyno Medical LLC · Pump, Infusion2 recalls258 reports
Other devices under the same FDA submission
3 devices cleared under K130690, K100705 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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